Senior Manager, Statistical Programming

BioNTech•Gaithersburg, MD

About The Position

As a Senior Manager, Statistical Programming at BioNTech, you will ensure high-quality statistical programming deliverables that support clinical development projects. Working with Clinical Development teams and CROs, you will oversee the creation and validation of programming outputs for study reports and regulatory submissions. The role drives process efficiencies, upholds quality standards, and contributes to global programming tools and standards for therapies in oncology and infectious diseases.

Requirements

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

Nice To Haves

An advanced degree.
Experience in oncology or infectious disease therapeutic areas.
Regulatory submission experience.

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, including analysis datasets, tables, listings, and figures.
Anticipate resource needs and coordinate with management on long-term resource allocation for therapeutic projects.
Ensure quality control of derived datasets, tables, listings, and figures in accordance with company standards and regulatory requirements.
Help develop global programming standards and create tools supporting SDTM/ADaM dataset generation and TLF production.
Provide functional expertise for 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, and critical illness insurance.
Pre-tax HSA and FSA and DCRA spending accounts.
24/7 Employee Assistance & Concierge Program (EAP).
Parental and childbirth leave and family planning assistance.
Virtual tutoring and childcare membership through Sitterstream.
Paid time off, including vacation, sick, bereavement, holidays, floating holidays, and a year-end U.S. shutdown.
401(k) plan with company match.
Tuition reimbursement and student loan assistance programs.
Wellbeing incentive platforms and incentives.
Professional development programs.
Commuting allowance and subsidized parking.
Discounted home, auto, and pet insurance.
Annual bonus and equity, variable and dependent on company and individual performance.