Director, Medical Information leading the function for delivering compliant scientific responses. Overseeing medical inquiry structure and ensuring high - quality medical information in biotech.
About the role
- Associate Director, Oncology Biometrics responsible for statistical methods in clinical trials. Collaborating on clinical study designs and analyses for drug development at Pfizer.
Responsibilities
- Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
- Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner.
- Provide statistical inputs on clinical development plans.
- Contribute to the development of clinical study protocols and author the statistical sections.
- Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses.
- Develop study randomization specification and verification documents as necessary.
- Perform sample size calculations and assess trial design operating characteristics under various assumptions.
- Advise the team on the most efficient design to meet study objectives.
- Review CRFs and edit checks and participate in UAT of different systems.
- Review dataset programming specifications, key derived variables, and statistical deliverables.
- Independently derive from source data key efficacy variables and analyses.
- Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations.
- Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner.
- Provide statistical leadership in clinical study team setting.
- May independently present at department, project team, or Sr. Management meetings.
- May lead inter-department projects involving other contributors.
Requirements
- Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master’s degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials
- FDA/EMA and other regulations knowledge
- ICH GCP guidelines knowledge
- Drug development process knowledge
- CDISC standards and implementation guides proficiency
- Statistical methods and applications to clinical trial design and data analysis proficiency
- Programming skills in R and/or SAS
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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