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Senior Director, Statistical Programming

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

About the Role:

Are you ready to lead and shape the future of statistical programming at BioNTech? As Senior Director, Statistical Programming, you will play a pivotal role in driving strategic and scientific leadership across integrated safety and efficacy analyses (ISS/ISE) at both program and platform levels. Your expertise will guide global submission efforts (NDA, BLA, MAA, PMDA) while championing innovation in technologies and processes. Join us to collaborate with cross-functional teams and contribute to BioNTech’s mission of translating scientific insights into life-changing therapies.

Your Contribution:

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

A Good Match:

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

Expected Pay Range (US): $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.

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BioNTech, the story

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, encourage 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 

www.biontech.com 

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