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BioNTech SE · 10 hours ago

Senior Director, Statistical Programming

Cambridge, MA

Full-time

Onsite

Director/Executive

$260K/yr - $315K/yr

18+ years exp

BioNTech SE is a leading biotechnology company focused on innovative therapies. They are seeking a Senior Director of Statistical Programming to provide strategic and scientific leadership in integrated safety and efficacy analyses, oversee global programming operations, and collaborate across teams to enhance data-driven decision-making.

Health Care

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

Qualification

Statistical ProgrammingSAS ProficiencyRegulatory SubmissionLeadership ExperienceR ProficiencyPython ProficiencyCDISC StandardsVendor ManagementData ManagementClinical DevelopmentCross-functional CollaborationSoft Skills

Required

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