Application Guide
How to Apply for Director Statistical Programming (Oncology)
at BioNTech
🏢 About BioNTech
BioNTech is a pioneering biotechnology company that gained global recognition for its mRNA COVID-19 vaccine but has a primary focus on oncology. They're unique for their mRNA-based individualized cancer immunotherapies and their 'pioneer-to-patient' approach that rapidly translates cutting-edge science into treatments. Working here means contributing to revolutionary cancer therapies while being part of a company that has proven it can deliver breakthrough medicines at scale.
About This Role
As Director of Statistical Programming for Oncology at BioNTech, you'll lead programming strategy and execution for cancer clinical trials, directly impacting drug development decisions and regulatory submissions. This role is critical because you'll ensure the statistical integrity of data that determines whether novel oncology therapies advance to patients, while managing vendor relationships and driving automation to accelerate BioNTech's ambitious oncology pipeline.
💡 A Day in the Life
You might start by reviewing programming deliverables from vendor CROs for an ongoing Phase III melanoma trial, then meet with Biostatistics to finalize the SAP for a new individualized neoantigen therapy study. Your afternoon could involve developing automation strategies for TLF generation across multiple oncology trials and preparing programming documentation for an upcoming MAA submission to the EMA.
🚀 Application Tools
🎯 Who BioNTech Is Looking For
- 15+ years (or 10+ with advanced degree) of pharmaceutical/CRO experience with demonstrated oncology trial expertise, particularly in late-phase studies and regulatory submissions
- Deep technical mastery of SAS (Base, macro, STAT, GRAPH, SQL) with experience implementing programming efficiency strategies and process automation
- Proven track record leading programming contributions to global regulatory submissions (NDAs/BLAs/MAAs) with specific knowledge of eCTD requirements
- Experience managing FSP programmers or vendor CROs in oncology trials while collaborating effectively with Biostatistics, Clinical Development, and Regulatory Affairs teams
📝 Tips for Applying to BioNTech
Quantify your oncology experience: specify how many oncology trials you've programmed for, phases (I-IV), and highlight any experience with individualized cancer immunotherapies or novel oncology endpoints
Demonstrate regulatory submission expertise: detail your specific contributions to oncology NDAs/BLAs/MAAs, mentioning therapeutic areas and regulatory agencies (FDA, EMA) you've worked with
Highlight automation and efficiency initiatives: describe specific programming automation, standardization, or vendor management improvements you've implemented in previous oncology roles
Research BioNTech's oncology pipeline: reference specific programs from their pipeline (like BNT111, BNT113, or BNT122) to show genuine interest in their specific cancer immunotherapy approaches
Emphasize UK/European regulatory experience: given the UK location, highlight any experience with MHRA, EMA submissions, or working in UK/European regulatory environments
✉️ What to Emphasize in Your Cover Letter
['Your specific experience programming for oncology clinical trials, particularly any work with cancer immunotherapies or novel oncology endpoints', 'Examples of leading programming contributions to successful regulatory submissions (mention specific submissions and therapeutic areas)', "How you've implemented programming efficiency strategies, automation, or vendor management improvements in previous roles", "Why BioNTech's mRNA-based individualized cancer immunotherapy approach specifically interests you and how your experience aligns"]
Generate Cover Letter →🔍 Research Before Applying
To stand out, make sure you've researched:
- → BioNTech's oncology pipeline (particularly their FixVac platform, iNeST platform, and specific programs like BNT111 for melanoma or BNT122 for colorectal cancer)
- → BioNTech's recent oncology clinical trial results and regulatory milestones (check their investor presentations and press releases)
- → BioNTech's collaborations in oncology (particularly with Genentech/Roche and their mRNA-based individualized neoantigen therapies)
- → BioNTech's UK presence and operations, including any specific oncology initiatives based in the UK
💬 Prepare for These Interview Topics
Based on this role, you may be asked about:
⚠️ Common Mistakes to Avoid
- Generic programming experience without specific oncology examples - BioNTech needs deep oncology therapeutic expertise
- Focusing only on COVID-19 vaccine experience without demonstrating oncology trial programming background
- Vague descriptions of regulatory submission contributions - they need specific examples of NDA/BLA/MAA programming leadership
📅 Application Timeline
This position is open until filled. However, we recommend applying as soon as possible as roles at mission-driven organizations tend to fill quickly.
Typical hiring timeline:
Application Review
1-2 weeks
Initial Screening
Phone call or written assessment
Interviews
1-2 rounds, usually virtual
Offer
Congratulations!