Senior Director, Statistical Programming
BioNTech SE
Full-time
Remote friendly (Cambridge, MA)
United States
$260,000 - $315,000 USD yearly
Operations
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Role Summary
Senior Director, Statistical Programming responsible for strategic leadership across integrated safety and efficacy analyses, global submission support, and the advancement of programming processes and technologies within BioNTech’s Biostatistics and Data Science functions.
Responsibilities
- 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.
- Partner with the Head of Statistical Programming to define and execute the global programming strategy, ensuring innovation, quality, and scalability.
- Collaborate with clinical development teams to influence analysis planning, interpretation, and data-driven decision-making at the program and platform levels.
- Oversight global programming operations, including internal teams and FSP partners, ensuring high-quality deliverables and operational consistency.
- Champion advanced technologies (R, Python, cloud automation, AI/ML) to optimize analysis workflows and increase efficiency.
- Establish and maintain robust programming processes and SOPs for integrated analyses and global submissions, promoting standardization and audit readiness across studies and submissions.
- Serve as senior escalation and governance lead for complex analytical, regulatory, or operational challenges.
- Promote continuous learning, inclusion, and collaboration across BioNTech’s global programming organization.
- Contribute to BioNTech’s broader Biostatistics and Data Science innovation agenda, helping translate scientific insights into robust analytic solutions.
Qualifications
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred with 18+ years (15+ years for advanced degree) experience in the pharmaceutical or CRO industry, including extensive experience leading integrated analysis and global submissions.
- Extensive leadership experience across integrated safety and efficacy analyses (ISS/ISE, INDs, pooled ADaM datasets) and global regulatory submission (NDA, BLA, MAA).
- Proven track record of strategic program-level oversight, vendor management, and cross-functional collaboration in Biostatistics, Clinical Development, Data Management, and Regulatory Affairs.
- Demonstrated experience in leading global teams and vendor/FSP partnership with strong governance and delivery oversight.
- 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, including eCTD, define.xml, and reviewers’ guide deliverables.
- 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) and the integrated evidence needs for both early and late-stage development.
Skills
- Strategic program oversight
- Global regulatory submission expertise
- Leadership and vendor/FSP management
- Programming languages: SAS, R, Python
- CDISC/SDTM/ADaM and integrated submissions
- Regulatory knowledge across FDA, EMA, PMDA, NMPA
- Collaboration and cross-functional influence
Education
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline; advanced degree preferred.