Senior Director, Statistical Programming
BioNTech SEGaithersburg, Maryland, United States • New Jersey, United States • Cambridge, Massachusetts, United States
Posted November 6, 2025
260000 - 315000 USD year
Full Time
About the Company
BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival.
Job Description
Senior Director, Statistical Programming: Provide strategic and scientific leadership across integrated safety and efficacy analyses (ISS/ISE) at the program and platform levels. Lead programming support for global submission (NDA, BLA, MAA, PMDA), including integrated datasets, TLFs, define.xml, and reviewers’ guides.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 18+ years (15+ years for advanced degree) experience in the pharmaceutical or CRO industry
- Extensive experience leading integrated analysis and global submissions
- Expert knowledge of SAS (Base, Macro, STAT, GRAPH, SQL); proficiency in R or Python strongly preferred
- Comprehensive understanding of FDA, EMA, PMDA, NMPA, ICH E3/E9, and global regulations and guidelines
- Deep understanding of CDISC standards (SDTM and ADaM) and integrated submission requirements (ISS/ISE)
- Strong familiarity with BioNTech’s core therapeutic areas (oncology and immunotherapy)
Benefits
- Competitive remuneration packages
- Annual bonus & equity
- Benefits determined by specific role, location of employment, and selected candidate’s qualifications and experience
