Senior Manager, Statistical Programming
BioNTech•Berkeley Heights, NJ
•Onsite
About The Position
As a Senior Manager, Statistical Programming at BioNTech, you will be instrumental in ensuring high-quality statistical programming deliverables that support our clinical development projects. Working collaboratively with Clinical Development teams or CROs, you will oversee the creation and validation of programming outputs for study reports and regulatory submissions. Your expertise will drive process efficiencies, uphold quality standards, and contribute to the development of global programming tools and standards. Join us to help advance groundbreaking therapies in oncology and infectious diseases.
Requirements
- BSc in Statistics, Mathematics, Computer Science, or related discipline
- 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
- 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
Nice To Haves
- advanced degree preferred
- submission experience preferred
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
