Senior Manager, Statistical Programming (Oncology)

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11351

About the Role

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.

Your Contribution

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

A Good Match

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

Your benefits and remuneration:

Expected Pay Range: $130,800/year to $209,400/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.

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

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! More details to be shared.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

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.