What are the responsibilities and job description for the Statistical Analysis Manager position at Meet?
About the Role
The Statistical Analysis Manager will oversee statistical analysis and interpretation of clinical trial data, serving as the statistical lead on several Phase 2 and 3 clinical trials. You will develop statistical analysis plans and mock tables, listings, and figures, reviewing clinical study data, regulatory documents, and supporting topline readouts and regulatory filings.
Key Responsibilities
What We're Looking For
The Statistical Analysis Manager will oversee statistical analysis and interpretation of clinical trial data, serving as the statistical lead on several Phase 2 and 3 clinical trials. You will develop statistical analysis plans and mock tables, listings, and figures, reviewing clinical study data, regulatory documents, and supporting topline readouts and regulatory filings.
Key Responsibilities
- Review clinical study data, regulatory documents, and support topline readouts and regulatory filings.
- Collaborate closely with all Biometrics functions, ensuring the quality of study data and the accuracy of statistical outputs.
- Develop statistical analysis plans, clinical study reports, protocols, and more.
- Manage and support the preparation of data packages for NDA and other regulatory submissions.
What We're Looking For
- Ph.D. in Biostatistics or equivalent, with a minimum of 6 years of experience (or Master's degree with at least 8 years of experience) in statistical analysis and programming support in the biotech/pharmaceutical industry.
- Experience with simulation work and multiple imputation analyses is a plus.
- Strong analytical skills, with the ability to think critically and solve complex problems.
