Scope The Director of Biostatistics provides strategic and operational leadership for biostatistical activities within and across clinical development programs.This role is responsible for ensuring the integrity, quality and rigor of statistical analyses and methodologies applied to clinical studies.They will serve as the primary statistical representative in cross-functional teams and lead biometrics related activities for regulatory submissions (IND, NDA/BLA, MAA).This role may supervise junior statisticians or function as a senior individual contributor.
Key responsibilities and duties: - Leads and oversee biostatistical strategy for one or more clinical development programs.
- Serves as a key contributor to study design and protocol development.
- Develops statistical analysis plans (SAPs) and table, listing, and figure (TLFs) shells.
- Ensures that clinical trial designs and proposed analysis methods are robust and follow regulatory guidelines (FDA, EMA, etc.)
- Oversees the production of TLFs for interim and final analyses and ensures that it is of high quality and delivered on time.
- Provides hands-on oversight of CROs and external statistical reporting groups to ensure quality standards and timelines are met for statistics related deliverables
- Manages statistical vendors for independent data monitoring committees
- May supervise junior biostatisticians
Education, qualifications and work experience: - Master's degree or PhD in biostatistics or statistics
- 15+ years of biotech/pharma experience as a biostatistician
- Demonstrated experience supporting pivotal and registrational clinical trials
- Strong CRO and vendor oversight experience
- Track record of delivering high quality statistical related deliverables
- NDA/BLA experience
Additional attributes: - Excellent knowledge of SAS
- Experience with sample size calculation software such as nQuery, EAST, etc.
- Knowledge of R a plus
Salary Range: $225,000 to $260,000 depending on education and relevant work experience
