Senior Director, Statistical Programming

Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US | full time | Job ID: 9662About 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 levelsLead programming support for global submissions, including integrated datasets, TLFs, define.xml files, and reviewers’ guidesPartner with the Head of Statistical Programming to define and execute a global programming strategy focused on innovation, scalability, and qualityCollaborate with clinical development teams to influence analysis planning, interpretation, and data-driven decision-makingOversee global programming operations—including internal teams and FSP partners—to ensure high-quality deliverables and operational consistencyChampion advanced technologies such as R, Python, cloud automation, and AI/ML to optimize workflows and enhance efficiencyEstablish robust programming processes and SOPs for integrated analyses and submissions to ensure standardization and audit readinessAct as a senior escalation point for complex analytical, regulatory, or operational challengesPromote continuous learning, inclusion, collaboration, and professional growth within BioNTech’s global programming organizationContribute to BioNTech’s broader Biostatistics and Data Science innovation agenda by translating scientific insights into robust analytic solutionsA Good Match:Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline; advanced degree preferred18+ 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 partnershipsExpert knowledge of SAS (Base/Macro/STAT/GRAPH/SQL); proficiency in R or Python strongly preferredComprehensive understanding of FDA/EMA/PMDA regulations including eCTD submissions, define.xml files, reviewers’ guides, CDISC standards (SDTM/ADaM), ISS/ISE requirementsFamiliarity with BioNTech’s core therapeutic areas—oncology/immunotherapy—and integrated evidence needs across drug development stagesExpected 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.