Senior Director, Statistical Programming

BioNTech SE • Cambridge, MA

46d

About The Position

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourageâ creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you

Requirements

• 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.

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.

Benefits

• BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
• We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 1,001-5,000 employees