Biostatistics Director

About the role

The Biostatistics Director leads the statistical strategy for real‑world evidence (RWE) initiatives, acting as the primary Biometrics liaison with Medical Affairs, HEOR and other cross‑functional teams. This senior position shapes study designs, analytical methods and the dissemination of findings to support regulatory, payer and clinical decision‑making.

Key responsibilities

• Develop and execute strategic and operational plans for RWE projects, ensuring scientific rigor.
• Serve as the statistical lead on health outcomes and epidemiology studies, guiding protocol and analysis plan development.
• Collaborate with internal stakeholders and manage external vendors to meet project timelines.
• Identify innovative opportunities for the use of real‑world data and drive methodological advancements.

Required profile

• Master’s degree in statistics/biostatistics with 10+ years of observational research leadership, or PhD with 7+ years of comparable experience.
• Extensive experience in designing and conducting prospective and retrospective observational studies for drug development, regulatory submissions and HTA engagements.
• Proven ability to mentor teams, influence cross‑functional partners and communicate results to both internal and external audiences.

Required skills

• Advanced proficiency with statistical software such as SAS or R.
• Experience applying statistical and machine‑learning models to administrative claims, electronic medical records and other real‑world data sources.