Director of Biostatistics
In this role, reporting to the Vice President of Biometrics, you will work with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing statistical deliverables outsourced to CROs. This is an exciting opportunity to contribute to the development of transformative therapies.
Responsibilities:
- Serve as a biostatistics expert for clinical programs.
- Provide strategic input for trial designs in early-phase and late-phase studies.
- Collaborate with internal and CRO team members to coordinate statistical deliverables.
- Conduct statistical modeling for efficient study designs and address statistical issues.
- Contribute to protocol development and author statistical analysis plans.
- Review eCRF designs to ensure data collection meets analysis requirements.
- Oversee QC/QA of statistical deliverables and perform ad hoc analyses as needed.
- Support IND/NDA/MAA regulatory submissions and address queries from regulatory agencies.
- Contribute to publications, including manuscripts and presentations.
- Lead standardization and process improvement efforts for the Biostatistics function.
Requirements:
- PhD in Statistics or related field, or MS with relevant experience.
- 8+ years in the pharmaceutical or biotech industry.
- Experience in clinical trial design, analysis, and reporting.
- Proficient in statistical programming (SAS and R).
- Familiarity with FDA, EMA, and ICH regulations.
- Strong communication and collaborative skills.