Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Jul GSK's Non-Clinical and Translational Statistics group plays a vital part at the birth of many prospective medicines and therapies through its work in helping top laboratory and product development teams, from the earliest stages of drug discovery through to the successful launch of new medicines. Our advanced modelling enables scientists to unravel the mechanisms of human disease, evaluate competing theories and explore potential new treatments using high-dimensional genomic and bioimaging data. The successful candidate for this Leader level position within the Translational and Biomarker Statistics team will serve as an expert scientific and functional leader. In this role, you will have the opportunity to be closely engaged in developing biomarker objectives for clinical projects, influencing translational medicine efforts and the development of companion diagnostics. Key Responsibilities Manage the assigned biomarker projects and provide timely support across all phases of drug development pipeline in collaboration with other functional area scientists. Propose and implement optimal and fit-for-purpose statistical and computational solutions for various biomarker studies. Identify and implement ways to improve efficiency of biomarker support such as development of tools for automation of data analysis and visualization. Embrace a wide range of classical and modern data analytic and predictive modelling (machine learning) methods and lead the development and evaluation of new methods and algorithms for research topics of greatest need. Significantly contribute to the external scientific community via conference presentations, publications and collaborations. Ensure the statistical robustness of prediction models such that all relevant uncertainty is correctly propagated through such models in order to inform the estimate of risk-discharge for any particular development plan option. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Master's degree in Statistics or Biostatistics Working experience in pharmaceutical industry Proven experience in a wide range of classical and modern statistical and machine learning methods, with good external reputation via strong publications and conference presentations. Demonstrated ability to apply innovative and fit-for-purpose statistical and predictive modelling methods for the analysis of biomarker and high dimensional data from clinical trials. Preferred Qualifications If you have the following characteristics, it would be a plus: PhD in statistics, computational methods or related field with focus on methods for genomics and related high-dimensional data analysis. Experience in early Drug Discovery Proven ability to learn, derive and apply innovative methodologies Good understanding of nonlinear mixed effects (Bayesian) models, the Pharmacometrics literature, and PK/PD modeling in general. A Bayesian mindset is an advantage. Strong communication skills both verbally and in writing Good collaboration and influencing skills in matrix working environments Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate. We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Sep 24, 2022
Full time
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Jul GSK's Non-Clinical and Translational Statistics group plays a vital part at the birth of many prospective medicines and therapies through its work in helping top laboratory and product development teams, from the earliest stages of drug discovery through to the successful launch of new medicines. Our advanced modelling enables scientists to unravel the mechanisms of human disease, evaluate competing theories and explore potential new treatments using high-dimensional genomic and bioimaging data. The successful candidate for this Leader level position within the Translational and Biomarker Statistics team will serve as an expert scientific and functional leader. In this role, you will have the opportunity to be closely engaged in developing biomarker objectives for clinical projects, influencing translational medicine efforts and the development of companion diagnostics. Key Responsibilities Manage the assigned biomarker projects and provide timely support across all phases of drug development pipeline in collaboration with other functional area scientists. Propose and implement optimal and fit-for-purpose statistical and computational solutions for various biomarker studies. Identify and implement ways to improve efficiency of biomarker support such as development of tools for automation of data analysis and visualization. Embrace a wide range of classical and modern data analytic and predictive modelling (machine learning) methods and lead the development and evaluation of new methods and algorithms for research topics of greatest need. Significantly contribute to the external scientific community via conference presentations, publications and collaborations. Ensure the statistical robustness of prediction models such that all relevant uncertainty is correctly propagated through such models in order to inform the estimate of risk-discharge for any particular development plan option. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Master's degree in Statistics or Biostatistics Working experience in pharmaceutical industry Proven experience in a wide range of classical and modern statistical and machine learning methods, with good external reputation via strong publications and conference presentations. Demonstrated ability to apply innovative and fit-for-purpose statistical and predictive modelling methods for the analysis of biomarker and high dimensional data from clinical trials. Preferred Qualifications If you have the following characteristics, it would be a plus: PhD in statistics, computational methods or related field with focus on methods for genomics and related high-dimensional data analysis. Experience in early Drug Discovery Proven ability to learn, derive and apply innovative methodologies Good understanding of nonlinear mixed effects (Bayesian) models, the Pharmacometrics literature, and PK/PD modeling in general. A Bayesian mindset is an advantage. Strong communication skills both verbally and in writing Good collaboration and influencing skills in matrix working environments Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate. We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Associate Director of Statistics - Top 5 Global Pharma - Greater London Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. We are looking for an Associate Director in Statistics for a pharmaceutical company to be based in the UK. In this role you will provide lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence specialising in Oncology. This is an exciting and challenging role for a candidate with a strong interest in, and a deep understanding of the fundamentals of statistical methods and approaches and to build on these skills to explore and discover new ways to contribute with innovative statistical approaches in a challenging business context in the support of Oncology research. Responsibilities: The Statistics Associate Director: Experience in assisting with the heavy lifting, filing and documentation, for example, the execution from a given design onwards, statistics methods and documentation and all that follows Effectively Partnering with project teams (including medical and commercial leads, statistical programming, data management, medical writing, RWE, HTA, Biomarkers, Pharmacometrics, Bioinformatics) identifying appropriate clinical trial designs by proposing quantitative decision rules suitable to informing key study endpoints and their operational characteristics, by implementing flawless data analysis and reporting internally and for relevant publications. Demonstrates strong technical, analytical and interpersonal skills in project teams, internal forums and external meetings to establish and maintain methodologies constructively influencing decision making and clinical development strategy. Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates sophisticated data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies sophisticated statistical methodology in assigned projects, such as clinical trials, with demonstrated coordinated disease/scientific/functional area understanding and health authority acceptability. Do you have the experience, skills and education we are looking for? PhD. in Statistics or related field or MSc in Statistics with track record of relevant problem-solving demonstrating advanced data analytic expertise based on a solid foundation of statistical principles and an ability to positively influence and support decision-making at program level and in regulatory interactions through effective communication. Proficient use of relevant computational tools for study, experiment, or trial research objectives (e.g. SAS, R, Python or similar) in individual workstations and in validated computer systems. Demonstrates knowledge of pharmaceutical research and development appropriate for providing leadership and support to experimental design, modelling, analysis planning, analysis execution, interpretation and statistical communication ideally in Oncology. Is a leader in the optimization of study designs through scenario simulations and sample size calculations based on relevant assumptions in line with study or indication level objectives. Understands and aligns choice of methods with relevant regulatory guidance. Has a track record for proposing, implementing, evaluating and successfully communicating complex innovative statistical ideas and methods leading to improved business practices. Follows organization and company standard operating procedures as appropriate, including training and project time accounting and standard methodologies ensuring data integrity. Takes responsibility for and welcomes constructive feedback on the quality and timeliness of the assigned project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Serves as a role model to statisticians and other scientists as appropriate. Shares knowledge within and across functions to ensure integrated delivery across all phases of drug development. Supervises contractors or staff as required on a project basis. Mentors junior colleagues in techniques, processes, and responsibilities. Provides input into hiring decisions and ongoing evaluation of talent. Actively pursues robust cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, researchers, investigators) to achieve results for project specific needs with focus on effective communication, efficiency, and productivity. Works cross-functionally to identify and problem solve when appropriate. What do you get in return? Working in a friendly group in exciting projects Excellent opportunities to develop and grow Home working flexibility Industry leading salary, annual bonus, and Long-Term Incentive Plan Extremely competitive benefits package What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible. Not what you're looking for? Please contact Aimee Weston at to arrange a confidential discussion about potential opportunities.
Sep 23, 2022
Full time
Associate Director of Statistics - Top 5 Global Pharma - Greater London Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. We are looking for an Associate Director in Statistics for a pharmaceutical company to be based in the UK. In this role you will provide lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence specialising in Oncology. This is an exciting and challenging role for a candidate with a strong interest in, and a deep understanding of the fundamentals of statistical methods and approaches and to build on these skills to explore and discover new ways to contribute with innovative statistical approaches in a challenging business context in the support of Oncology research. Responsibilities: The Statistics Associate Director: Experience in assisting with the heavy lifting, filing and documentation, for example, the execution from a given design onwards, statistics methods and documentation and all that follows Effectively Partnering with project teams (including medical and commercial leads, statistical programming, data management, medical writing, RWE, HTA, Biomarkers, Pharmacometrics, Bioinformatics) identifying appropriate clinical trial designs by proposing quantitative decision rules suitable to informing key study endpoints and their operational characteristics, by implementing flawless data analysis and reporting internally and for relevant publications. Demonstrates strong technical, analytical and interpersonal skills in project teams, internal forums and external meetings to establish and maintain methodologies constructively influencing decision making and clinical development strategy. Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates sophisticated data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies sophisticated statistical methodology in assigned projects, such as clinical trials, with demonstrated coordinated disease/scientific/functional area understanding and health authority acceptability. Do you have the experience, skills and education we are looking for? PhD. in Statistics or related field or MSc in Statistics with track record of relevant problem-solving demonstrating advanced data analytic expertise based on a solid foundation of statistical principles and an ability to positively influence and support decision-making at program level and in regulatory interactions through effective communication. Proficient use of relevant computational tools for study, experiment, or trial research objectives (e.g. SAS, R, Python or similar) in individual workstations and in validated computer systems. Demonstrates knowledge of pharmaceutical research and development appropriate for providing leadership and support to experimental design, modelling, analysis planning, analysis execution, interpretation and statistical communication ideally in Oncology. Is a leader in the optimization of study designs through scenario simulations and sample size calculations based on relevant assumptions in line with study or indication level objectives. Understands and aligns choice of methods with relevant regulatory guidance. Has a track record for proposing, implementing, evaluating and successfully communicating complex innovative statistical ideas and methods leading to improved business practices. Follows organization and company standard operating procedures as appropriate, including training and project time accounting and standard methodologies ensuring data integrity. Takes responsibility for and welcomes constructive feedback on the quality and timeliness of the assigned project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Serves as a role model to statisticians and other scientists as appropriate. Shares knowledge within and across functions to ensure integrated delivery across all phases of drug development. Supervises contractors or staff as required on a project basis. Mentors junior colleagues in techniques, processes, and responsibilities. Provides input into hiring decisions and ongoing evaluation of talent. Actively pursues robust cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, researchers, investigators) to achieve results for project specific needs with focus on effective communication, efficiency, and productivity. Works cross-functionally to identify and problem solve when appropriate. What do you get in return? Working in a friendly group in exciting projects Excellent opportunities to develop and grow Home working flexibility Industry leading salary, annual bonus, and Long-Term Incentive Plan Extremely competitive benefits package What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible. Not what you're looking for? Please contact Aimee Weston at to arrange a confidential discussion about potential opportunities.
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
Sep 23, 2022
Full time
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
Manager, Biostatistics - FSP team Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Sep 23, 2022
Full time
Manager, Biostatistics - FSP team Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Sep 23, 2022
Full time
JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of clinical development. We deliver to the market high impact statistical consultancy on clinical development plans and individual trials, innovative analytical software for statistical analysis and simulation, and best-in-class data science analytics services. Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, and Asia, Cytel hires passionate and talented people who share its mission of ensuring the development of safe and effective health technologies. We are hiring a Managing Consultant to join our Strategic Consulting Practice. As a seasoned Biostatistician, you will leverage and broaden Cytel's reputation for thought leadership and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with clients in collaboration with Cytel's business developers and other personnel related to the account. This includes developing and demonstrating thought leadership in statistical methodology for clinical development, ensuring that Cytel remains at the leading edge, and raising Cytel brand awareness and recognition throughout the industry. Specifically, we are looking for leaders with a strong foundation in statistics plus broad expertise and/or unique knowledge in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory, clinical and/or market access pathways and promote faster patient access to better health technologies. * Specific duties and responsibilities: * * Provides strategic advice on client projects, collaborating with an integrated team of Strategic Consultants and Analysts to define optimal regulatory, clinical and/or market access pathways. Adapts precedent and develops innovative solutions impartially selecting and combining traditional and novel approaches. * Assumes overall responsibility for assigned Strategic Consulting accounts and projects, acting as the client's primary point of contact for Strategic Consulting engagements, developing mutually beneficial partnerships and taking ownership for the strategic needs of the client. * Depending on experience, creates, identifies and pursues new business opportunities both within Strategic Consulting and across Cytel Business Units by identifying emerging customer needs and formulating appropriate solutions to meet revenue, profitability and customer satisfaction objectives. * The position requires regular travel, substantial direct contact with senior management and executives at prospects and existing clients, and the ability to build and leverage strong interpersonal business relationships both internally and externally to Cytel. * Qualifications and Experience: * * Thorough understanding of the biopharmaceutical R&D process in combination with solid business acumen and an appreciation of the broader business issues. * Strategic thinker with a global orientation, strong problem-solving and analytical skills, and the ability to execute in complex situations at the tactical level. * Comfortable presenting and interfacing with senior executives within the clients. * Experience interacting with regulatory agencies (FDA/EMA) and key opinion leaders to enhance development plans. * Proven management skills with the ability to build, mentor and motivate a strong team of consultants and analysts. * Collaborative, entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. * Minimum of a Masters (PhD desirable) in Mathematics, Biostatistics or a related field; MBA, MD or advanced degree highly desirable; at least 10-15 years of experience in the clinical trials or health research environment. * Why Cytel? * * You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development * You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to progress to leadership positions within the company * You will work with and leverage the best and brightest minds in the industry . #LI-KO1
Feb 26, 2022
Full time
As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of clinical development. We deliver to the market high impact statistical consultancy on clinical development plans and individual trials, innovative analytical software for statistical analysis and simulation, and best-in-class data science analytics services. Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, and Asia, Cytel hires passionate and talented people who share its mission of ensuring the development of safe and effective health technologies. We are hiring a Managing Consultant to join our Strategic Consulting Practice. As a seasoned Biostatistician, you will leverage and broaden Cytel's reputation for thought leadership and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with clients in collaboration with Cytel's business developers and other personnel related to the account. This includes developing and demonstrating thought leadership in statistical methodology for clinical development, ensuring that Cytel remains at the leading edge, and raising Cytel brand awareness and recognition throughout the industry. Specifically, we are looking for leaders with a strong foundation in statistics plus broad expertise and/or unique knowledge in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory, clinical and/or market access pathways and promote faster patient access to better health technologies. * Specific duties and responsibilities: * * Provides strategic advice on client projects, collaborating with an integrated team of Strategic Consultants and Analysts to define optimal regulatory, clinical and/or market access pathways. Adapts precedent and develops innovative solutions impartially selecting and combining traditional and novel approaches. * Assumes overall responsibility for assigned Strategic Consulting accounts and projects, acting as the client's primary point of contact for Strategic Consulting engagements, developing mutually beneficial partnerships and taking ownership for the strategic needs of the client. * Depending on experience, creates, identifies and pursues new business opportunities both within Strategic Consulting and across Cytel Business Units by identifying emerging customer needs and formulating appropriate solutions to meet revenue, profitability and customer satisfaction objectives. * The position requires regular travel, substantial direct contact with senior management and executives at prospects and existing clients, and the ability to build and leverage strong interpersonal business relationships both internally and externally to Cytel. * Qualifications and Experience: * * Thorough understanding of the biopharmaceutical R&D process in combination with solid business acumen and an appreciation of the broader business issues. * Strategic thinker with a global orientation, strong problem-solving and analytical skills, and the ability to execute in complex situations at the tactical level. * Comfortable presenting and interfacing with senior executives within the clients. * Experience interacting with regulatory agencies (FDA/EMA) and key opinion leaders to enhance development plans. * Proven management skills with the ability to build, mentor and motivate a strong team of consultants and analysts. * Collaborative, entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. * Minimum of a Masters (PhD desirable) in Mathematics, Biostatistics or a related field; MBA, MD or advanced degree highly desirable; at least 10-15 years of experience in the clinical trials or health research environment. * Why Cytel? * * You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development * You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to progress to leadership positions within the company * You will work with and leverage the best and brightest minds in the industry . #LI-KO1
For over thirty years, Cytel has enabled the world's biotech and pharmaceutical companies to make confident, evidence-based decisions to ensure successful outcomes. As industry leaders in delivering advanced data analytics solutions, we continually invest in deepening our expertise. In 2020, we joined forces with specialist consultancies, Ingress Health and Purple Squirrel Economics, to create a global team of experts providing industry-leading capabilities in health economics and outcomes research (HEOR) and real-world evidence (RWE). Powered by the unique experience and expertise of our researchers and consultants around the world, we conceptualize and execute HEOR and RWE studies, using advanced quantitative techniques to prepare sponsors for regulatory submission and to support their product's clinical and economic value proposition. Our mission is to help you unlock the full promise of your data. Our teams conduct evidence synthesis, economic analyses, and comparative effectiveness studies to generate the evidence to support the overall value of your product, and our experts translate evidence into concise value propositions. * Comparative effectiveness and economic analyses * Evidence synthesis, value communications, and market access strategy * RWE projects and studies Through our advanced analytics, Cytel provides the richer, deeper insights necessary for making confident development decisions. We generate evidence that complements traditional randomized clinical trials, accelerates submissions, expands indications, and supports health-economic decision-making. At Cytel, we're designed for results. * Overview: Research Associate * This position is a great opportunity to start your career in a growing company that provides value-driven services to support our clients in pharma and biotech and, ultimately, improve patient access. The Research Associate is a key role in Value Communications with excellent opportunities for growth for the right candidate. This is a team-based role in which you will have the opportunity to collaborate with writers, consultants, health economists, statisticians, and evidence generation specialists working on health economics outcomes research (HEOR) and market access (MA) projects for a variety of therapeutic areas. * Typical duties include: * * Creating PowerPoint presentations based on scientific evidence * Under the direction of a project lead, writing fully-referenced content for deliverables such as Academy of Managed Care Pharmacy (AMCP) dossiers, global value dossiers, and scientific manuscripts based on published clinical, scientific, and pharmacoeconomic evidence * Developing simple visuals and graphics in PowerPoint or Excel * Basic editing, formatting, and quality assurance * Creating reference libraries, highlighting pdf references, and performing some data crosschecking * Daily communication and teamwork with Value Communications teammates and other teams such as Evidence Curation and Health Economics * Conducting internet searches, including focused literature reviews using PubMed (not SLRs), journal and conference websites, etc * Helping with manuscript submissions as needed * Developing posters for conferences based on approved content The successful candidate is an enthusiastic, driven, and detail-oriented individual who works well independently and as part of a team. Adaptability and excellent verbal and written communication skills are essential. * Education, Professional Skills & Experience: * Advanced degree in life sciences, health economics, or a clinical discipline is preferred, e.g., MS, MPH * Experience with scientific or medical writing * Ability to understand and clearly communicate clinical, economic, and commercial information, * Research skills (ie, able to run focused searches in PubMed) * Proficiency Microsoft Word, PowerPoint, and Excel * Experience with referencing software (EndNote and/or Zotero preferred) * Outstanding attention to detail * Enthusiasm to learn more about MA and HEOR Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
Feb 26, 2022
Full time
For over thirty years, Cytel has enabled the world's biotech and pharmaceutical companies to make confident, evidence-based decisions to ensure successful outcomes. As industry leaders in delivering advanced data analytics solutions, we continually invest in deepening our expertise. In 2020, we joined forces with specialist consultancies, Ingress Health and Purple Squirrel Economics, to create a global team of experts providing industry-leading capabilities in health economics and outcomes research (HEOR) and real-world evidence (RWE). Powered by the unique experience and expertise of our researchers and consultants around the world, we conceptualize and execute HEOR and RWE studies, using advanced quantitative techniques to prepare sponsors for regulatory submission and to support their product's clinical and economic value proposition. Our mission is to help you unlock the full promise of your data. Our teams conduct evidence synthesis, economic analyses, and comparative effectiveness studies to generate the evidence to support the overall value of your product, and our experts translate evidence into concise value propositions. * Comparative effectiveness and economic analyses * Evidence synthesis, value communications, and market access strategy * RWE projects and studies Through our advanced analytics, Cytel provides the richer, deeper insights necessary for making confident development decisions. We generate evidence that complements traditional randomized clinical trials, accelerates submissions, expands indications, and supports health-economic decision-making. At Cytel, we're designed for results. * Overview: Research Associate * This position is a great opportunity to start your career in a growing company that provides value-driven services to support our clients in pharma and biotech and, ultimately, improve patient access. The Research Associate is a key role in Value Communications with excellent opportunities for growth for the right candidate. This is a team-based role in which you will have the opportunity to collaborate with writers, consultants, health economists, statisticians, and evidence generation specialists working on health economics outcomes research (HEOR) and market access (MA) projects for a variety of therapeutic areas. * Typical duties include: * * Creating PowerPoint presentations based on scientific evidence * Under the direction of a project lead, writing fully-referenced content for deliverables such as Academy of Managed Care Pharmacy (AMCP) dossiers, global value dossiers, and scientific manuscripts based on published clinical, scientific, and pharmacoeconomic evidence * Developing simple visuals and graphics in PowerPoint or Excel * Basic editing, formatting, and quality assurance * Creating reference libraries, highlighting pdf references, and performing some data crosschecking * Daily communication and teamwork with Value Communications teammates and other teams such as Evidence Curation and Health Economics * Conducting internet searches, including focused literature reviews using PubMed (not SLRs), journal and conference websites, etc * Helping with manuscript submissions as needed * Developing posters for conferences based on approved content The successful candidate is an enthusiastic, driven, and detail-oriented individual who works well independently and as part of a team. Adaptability and excellent verbal and written communication skills are essential. * Education, Professional Skills & Experience: * Advanced degree in life sciences, health economics, or a clinical discipline is preferred, e.g., MS, MPH * Experience with scientific or medical writing * Ability to understand and clearly communicate clinical, economic, and commercial information, * Research skills (ie, able to run focused searches in PubMed) * Proficiency Microsoft Word, PowerPoint, and Excel * Experience with referencing software (EndNote and/or Zotero preferred) * Outstanding attention to detail * Enthusiasm to learn more about MA and HEOR Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
Principal Statistician Remote Have you got experience in the application of statistics in the pharmaceutical, healthcare or life science sectors? Do you want to be at the forefront of statistical innovations, leading the way on clinical trial design and analysis? Are you looking for an opportunity that offers you a flexible work solution and one that will take your career to the next level of responsibility? Would you like to join a dynamic, growing firm where you can really make an impact, not just on the company but to accelerate drug development and ultimately benefit patients? A Principal Statistician is required for a fast-growing enabling technology company who provide world-class analytics and specialised software products for clinical-stage life science organisations. Their experienced statisticians and programmers develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine and real-world data analytics. The Principal Statistician will join their Statistical Consulting team to deliver high quality, cutomer-focused, innovative, design and analytical services within a clinical and wider drug-development setting as their platform moves into the next phase. On offer is a competitive salary up to £70,000 with extensive benefits including generous holiday entitlement (37 days), pension scheme and private health insurance. This role can be worked fully remotely with regular meetings over video. Key responsibilities of the Principal Statistician: Assisting customers with their study design with a particular focus on simulation to ensure they are aligned with the study objectives Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports Summarise, analyse and visualise study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/cost estimates Collaborate with the Product Development team defining key features and statistical aspects. Provide input and support to Marketing, including demonstrations to clients, white-papers, etc. Statistical leadership - whether for team members on projects, mentoring more junior statisticians, or functioning as an expert on statistical methods, processes, or clinical trial methodology Client engagement - build and maintain positive customer relationships with regards to statistical Essential skillset of the Principal Statistician Degree in mathematics, statistics, physics, pharmacology or with a strong statistical component Significant track record in the application of medical statistics (pharma, CRO, academic) Willingness to engage with clients to understand and research problems and provide creative, business-orientated solutions Experience in delivering customer projects to high quality standards Ability to communicate clearly in both written and spoken English Experience in SAS and/or R statistical software packages Proven track record in influencing drug development through the application of statistical thinking (pharma, CRO, academic) Desirable skillset: Higher degree in statistics or similar scientific discipline Experience in study design and protocol and report-writing Experience of modelling and simulation techniques to explore complex study designs Experience of Bayesian approaches to design and analysis of clinical data Experience of early-phase drug development processes including innovative/adaptive study design
Sep 12, 2021
Full time
Principal Statistician Remote Have you got experience in the application of statistics in the pharmaceutical, healthcare or life science sectors? Do you want to be at the forefront of statistical innovations, leading the way on clinical trial design and analysis? Are you looking for an opportunity that offers you a flexible work solution and one that will take your career to the next level of responsibility? Would you like to join a dynamic, growing firm where you can really make an impact, not just on the company but to accelerate drug development and ultimately benefit patients? A Principal Statistician is required for a fast-growing enabling technology company who provide world-class analytics and specialised software products for clinical-stage life science organisations. Their experienced statisticians and programmers develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine and real-world data analytics. The Principal Statistician will join their Statistical Consulting team to deliver high quality, cutomer-focused, innovative, design and analytical services within a clinical and wider drug-development setting as their platform moves into the next phase. On offer is a competitive salary up to £70,000 with extensive benefits including generous holiday entitlement (37 days), pension scheme and private health insurance. This role can be worked fully remotely with regular meetings over video. Key responsibilities of the Principal Statistician: Assisting customers with their study design with a particular focus on simulation to ensure they are aligned with the study objectives Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports Summarise, analyse and visualise study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/cost estimates Collaborate with the Product Development team defining key features and statistical aspects. Provide input and support to Marketing, including demonstrations to clients, white-papers, etc. Statistical leadership - whether for team members on projects, mentoring more junior statisticians, or functioning as an expert on statistical methods, processes, or clinical trial methodology Client engagement - build and maintain positive customer relationships with regards to statistical Essential skillset of the Principal Statistician Degree in mathematics, statistics, physics, pharmacology or with a strong statistical component Significant track record in the application of medical statistics (pharma, CRO, academic) Willingness to engage with clients to understand and research problems and provide creative, business-orientated solutions Experience in delivering customer projects to high quality standards Ability to communicate clearly in both written and spoken English Experience in SAS and/or R statistical software packages Proven track record in influencing drug development through the application of statistical thinking (pharma, CRO, academic) Desirable skillset: Higher degree in statistics or similar scientific discipline Experience in study design and protocol and report-writing Experience of modelling and simulation techniques to explore complex study designs Experience of Bayesian approaches to design and analysis of clinical data Experience of early-phase drug development processes including innovative/adaptive study design
Geoff King at RBW Consulting is supporting a game-changing CRO that is reinventing the way therapies are developed in the recruitment of a Principal Biostatistician to join a multi-sponsor Oncology team. As a forward thinking, top 10 global CRO you will have the opportunity to work with some of the biggest and best pharmaceutical companies in the world on blockbuster drug trials. You will have excellent training and development opportunities, competitive salary & benefits and the chance to improve patients' lives around the world. *Responsibilities* * Develop department Standard Operating Procedures (SOPs) and guidelines * Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget. * Responsible for staff development, training and retention. * Participates actively in hiring, onboarding, transferring, and terminating staff. * Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines. * Supports the assignment of, or directly assigns Biostatisticians to projects * Supports business development activities. * Minimal travel may be required. *Requirements:* * Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians * Previous management experience of remote teams * Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis * Proficiency in SAS programming * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel may be required A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is supporting a game-changing CRO that is reinventing the way therapies are developed in the recruitment of a Principal Biostatistician to join a multi-sponsor Oncology team. As a forward thinking, top 10 global CRO you will have the opportunity to work with some of the biggest and best pharmaceutical companies in the world on blockbuster drug trials. You will have excellent training and development opportunities, competitive salary & benefits and the chance to improve patients' lives around the world. *Responsibilities* * Develop department Standard Operating Procedures (SOPs) and guidelines * Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget. * Responsible for staff development, training and retention. * Participates actively in hiring, onboarding, transferring, and terminating staff. * Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines. * Supports the assignment of, or directly assigns Biostatisticians to projects * Supports business development activities. * Minimal travel may be required. *Requirements:* * Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians * Previous management experience of remote teams * Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis * Proficiency in SAS programming * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel may be required A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Geoff King at RBW Consulting is working with a specialist Clinical Research Organisation to the pharmaceutical industry in the recruitment of multiple Senior or Principal Biostatisticians to join their FSP and embedded model teams as they continue to support a number of the worlds most cutting edge pharmaceutical companies. As a CRO focused on delivering high quality statistics and programming support to these companies you will have the opportunity to work across multiple therapeutic area on phase I-IV clinical trials. This company prides themselves on their friendly and supportive culture where you will receive help on trials no matter how big or small the request. They also provide constant opportunities for promotion and growth due to their investment on staff and defined career plans. *Main duties & responsibilities:* • Perform technical and consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs. • Author simple and complex study SAP and TFL shells. • Author and review simple and complex dataset standards. • Perform data checks and data exploration (e.g. using frequencies, histograms). • Identify data and standards issues and resolve or escalate as appropriate. • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice. • Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation. • Perform literature review and ability to extract and collate relevant information and data from external papers as needed. • Identify and implement appropriate sample size method using software or simulations. • Support study team in providing study design options. • Review of project management related documents. • Maintain study master file documents and any other documents that are required to be audit ready. • Lead internal and client study team meetings effectively. *Key requirements:* • MSc or PhD in Statistics/Biostatistics (or equivalent). • At least 3 years of relevant industry experience. • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs. • Awareness of industry and project standards & ICH guidelines. • Excellent verbal and written communication skills. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is working with a specialist Clinical Research Organisation to the pharmaceutical industry in the recruitment of multiple Senior or Principal Biostatisticians to join their FSP and embedded model teams as they continue to support a number of the worlds most cutting edge pharmaceutical companies. As a CRO focused on delivering high quality statistics and programming support to these companies you will have the opportunity to work across multiple therapeutic area on phase I-IV clinical trials. This company prides themselves on their friendly and supportive culture where you will receive help on trials no matter how big or small the request. They also provide constant opportunities for promotion and growth due to their investment on staff and defined career plans. *Main duties & responsibilities:* • Perform technical and consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs. • Author simple and complex study SAP and TFL shells. • Author and review simple and complex dataset standards. • Perform data checks and data exploration (e.g. using frequencies, histograms). • Identify data and standards issues and resolve or escalate as appropriate. • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice. • Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation. • Perform literature review and ability to extract and collate relevant information and data from external papers as needed. • Identify and implement appropriate sample size method using software or simulations. • Support study team in providing study design options. • Review of project management related documents. • Maintain study master file documents and any other documents that are required to be audit ready. • Lead internal and client study team meetings effectively. *Key requirements:* • MSc or PhD in Statistics/Biostatistics (or equivalent). • At least 3 years of relevant industry experience. • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs. • Awareness of industry and project standards & ICH guidelines. • Excellent verbal and written communication skills. A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page.
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 23, 2021
Full time
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.