Principal Biostatistician FSP - Medical Affairs
About the role
Job Description Medical Affairs Biostatistician
The role is responsible for statistical activities in support of Medical Affairs, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed. In addition, this role is also responsible delivering analysis outputs without programmers support.
Responsibilities Summary of Key Responsibilities
- Leads statistical support for post approval value evidence generation and reimbursement submissions
- Conducts post hoc analysis to support publications and presentations
- Reviews and authors abstract, manuscript, regulatory documents
- Collaborates with cross-functional team to support observational studies
- Develops statistical sections of study protocols and statistical analysis plans.
- Collaborates with Data Management and Medical Research on design of eCRFs.
- Provides statistical guidance on conduct of ongoing studies.
- Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
- Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
- Contributes to scientific articles, summarizing data collected in sponsor studies.
- Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
Qualifications QUALIFICATIONS
- PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.
- Excellent written and oral communication and presentation skills.
- Strong SAS programming experiences and expertise and are comfortable delivering analysis outputs without programmers support.
- Extensive experiences working on data analysis with clinical studies database
- Experience working on post-approval observational and clinical studies.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Experiences in R programming language and other statistical software.
- Experience with CDISC, including SDTM, ADaM, CDASH.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
Principal Biostatistician FSP - Medical Affairs
About the role
Job Description Medical Affairs Biostatistician
The role is responsible for statistical activities in support of Medical Affairs, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed. In addition, this role is also responsible delivering analysis outputs without programmers support.
Responsibilities Summary of Key Responsibilities
- Leads statistical support for post approval value evidence generation and reimbursement submissions
- Conducts post hoc analysis to support publications and presentations
- Reviews and authors abstract, manuscript, regulatory documents
- Collaborates with cross-functional team to support observational studies
- Develops statistical sections of study protocols and statistical analysis plans.
- Collaborates with Data Management and Medical Research on design of eCRFs.
- Provides statistical guidance on conduct of ongoing studies.
- Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
- Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
- Contributes to scientific articles, summarizing data collected in sponsor studies.
- Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
Qualifications QUALIFICATIONS
- PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.
- Excellent written and oral communication and presentation skills.
- Strong SAS programming experiences and expertise and are comfortable delivering analysis outputs without programmers support.
- Extensive experiences working on data analysis with clinical studies database
- Experience working on post-approval observational and clinical studies.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Experiences in R programming language and other statistical software.
- Experience with CDISC, including SDTM, ADaM, CDASH.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.