Senior Director, Statistical Programming (Cambridge, MA, US, MA 02139) chez BioNTech

Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US   |   full time   |   Job ID: 9662 

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.

Expected Pay Range: $260,000/year to $315,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your 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.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.