Collaborate with Clinical Development teams or CROs to meet project timelines for statistical data analysis and reporting
Oversee or independently produce and validate programming deliverables such as analysis datasets, tables, listings, and figures
Anticipate resource needs and coordinate with management to ensure long-term resource allocation for therapeutic projects
Ensure quality control (QC) is performed on all derived datasets, tables, listings, and figures in alignment with company standards and regulatory requirements
Participate in developing global programming standards to enable consistent deliverables across portfolios; create tools supporting SDTM/ADaM dataset generation and TLF production
Provide functional expertise in establishing BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
Collaborate with Biostatistics to develop statistical applications such as data review and reporting tools
Support regulatory submissions by preparing data submission packages including define.xml

BSc in Statistics, Mathematics, Computer Science, or related discipline; advanced degree preferred
5+ years (3+ years with advanced degree) experience in pharmaceutical industry/CRO/clinical research settings
Strong competence in statistical programming (e.g., SAS/Base, Macro, STAT, GRAPH, SQL)
Solid knowledge of FDA/EMA/ICH regulations and guidelines governing clinical trials
Familiarity with industry standards for clinical study data reporting (e.g., CDISC standards)
Experience in oncology therapeutic area; submission experience preferred
Project management skills with strong organizational abilities and attention to detail
Excellent communication skills (written/spoken English) with a proactive mindset for problem-solving
Ability to thrive in a fast-paced team environment while maintaining analytical rigor

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more!

Senior Manager, Statistical Programming

Key skills