Sr. Manager/ AD Biostatistics
- Biostatistics | FDA Experience | Cardio and Neurology
- South San Francisco, California
- $140,000 - $200,000 +complete benefits package
A late stage biopharmaceutical company is looking to hire a Sr Manager/AD Biostatistics to become a part of the growing Biometrics (Biostatistics, Statistical Programming, and Clinical Data Management) team.
The Sr Manager/AD Biostatistics will have responsibilities that include:
- Partake in strategic planning and create optimal clinical development plans with cross-functional drug development groups.
- Accountable for writing statistical methodology section of the protocol, including sample size calculation.
- Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE.
- Assist and contribute in the preparation of study reports, regulatory submissions and annual IND safety update reports.
- Perform ad hoc analyses and validation of analysis results.
- Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes, including IWRS/EDC, STDM, statistical programming for TLFs and data reporting.
The ideal candidate will have the following skill set:
- PhD. in statistics/biostatistics with minimum 6-10 years of biopharmaceutical statistics experience; Master's degree in statistics or biostatistics with a minimum of 8-12 years of experience with specific experience in late stage drug development, including phase IIb, phase III and submissions in the pharmaceutical industry.
- Experience in Biostatistics, SAS programming and clinical data management in a regulated clinical research environment.
- Knowledge of adaptive design, missing data handling, multiple comparisons and simulation techniques.
- Experience in organizing regulatory submissions, such as BLA, NDA, sNDA and MAA submissions.
- Good working knowledge of ICH, FDA and GCP regulations and guidelines.
- Strong leadership skills and team work spirit.
- Experience in neurology/cardiovascular therapeutic areas is desirable.