Provide strategic and scientific leadership for integrated safety and efficacy analyses (ISS/ISE) at program and platform levels
Lead programming support for global submissions, including integrated datasets, TLFs, define.xml files, and reviewers’ guides
Partner with the Head of Statistical Programming to define and execute a global programming strategy focused on innovation, scalability, and quality
Collaborate with clinical development teams to influence analysis planning, interpretation, and data-driven decision-making
Oversee global programming operations—including internal teams and FSP partners—to ensure high-quality deliverables and operational consistency
Champion advanced technologies such as R, Python, cloud automation, and AI/ML to optimize workflows and enhance efficiency
Establish robust programming processes and SOPs for integrated analyses and submissions to ensure standardization and audit readiness
Act as a senior escalation point for complex analytical, regulatory, or operational challenges
Promote continuous learning, inclusion, collaboration, and professional growth within BioNTech’s global programming organization
Contribute to BioNTech’s broader Biostatistics and Data Science innovation agenda by translating scientific insights into robust analytic solutions

Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline; advanced degree preferred
18+ years (15+ years with advanced degree) of experience in pharmaceutical/CRO industries with extensive leadership in integrated analysis (ISS/ISE) and global submissions (NDA/BLA/MAA)
Proven track record of strategic oversight at the program level with experience in vendor management and cross-functional collaboration (Biostatistics, Clinical Development, Data Management)
Extensive experience leading global teams with strong governance frameworks for vendor/FSP partnerships
Expert knowledge of SAS (Base/Macro/STAT/GRAPH/SQL); proficiency in R or Python strongly preferred
Comprehensive understanding of FDA/EMA/PMDA regulations including eCTD submissions, define.xml files, reviewers’ guides, CDISC standards (SDTM/ADaM), ISS/ISE requirements
Familiarity with BioNTech’s core therapeutic areas—oncology/immunotherapy—and integrated evidence needs across drug development stages.

Senior Director, Statistical Programming

Key skills