A top 10 biopharmaceutical company is looking to hire an AD Biostatistics to become a part of the growing biostats team.
The 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 mock-up TLFs) for individual studies and ISS/ISE.
- Assist and contribute to the preparation of study reports, regulatory submissions and annual IND safety update reports.
- Collaborate with internal and external stakeholders to ensure data instruments and implementation meet project needs.
- Act as a liaison between team and external scientific contacts.
- 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:
- D. in statistics/biostatistics with minimum 5-10 years of biopharmaceutical statistics experience; Master's degree in statistics or biostatistics with a minimum of 8-12 years of experience in a highly related field.
- 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.
