Mainz, Germany | full time | Job ID: 11032

About the role.

BioNTech is seeking an experienced Statistical Expert (Director Analytical Development (Statistics CMC) to support our Analytical Development team. You will develop statistical guidelines, perform analyses, and ensure compliance with global regulatory standards. Your expertise will optimize method development workflows and contribute to regulatory filings focused on analytical methods and product quality.

Your contribution.

• Develop and implement statistical guidelines for method development and comparability studies, including Design of Experiments (DoE) and design space approaches aligned with ICH guidelines.
• Perform statistical analyses (primarily frequentist, and where beneficial Bayesian approaches) for method development, validation, stability studies, comparability assessments, and regulatory filings.
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results using structured data analysis and simulations.
• Analyse stability studies and shelf-life data, perform trend modelling, and estimate shelf-life using regression models, and prediction/tolerance intervals.
• Prepare high-quality statistical data packages for regulatory submissions and respond to related queries.
• Provide statistical training to enhance organizational capabilities while staying updated on advancements in the field.

A good match.

• Advanced degree in statistics, mathematics, or related field (PhD or Master’s preferred).
• Proven experience in pharma/biotech analytical development (7+ years), ideally including RNA therapeutics or biologics.
• Strong knowledge of FDA, EMA, and ICH regulations for CMC processes.
• Proficiency in statistical software tools such as Minitab and JMP.
• Analytical mindset with the ability to independently design, execute, and evaluate statistical analyses.
• Excellent communication skills (German and English) to explain complex concepts clearly across multidisciplinary teams.

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Apply now

• We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 11032 (please always specify if you have any questions)

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 ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.