Statistical Expert CMC - Analytical Development

Overview

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.

Responsibilities

• 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.

Qualifications

• 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.

Benefits and Support

• Your flexibility: flexible hours | vacation account
• 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 life phases: Employer-funded pension | Childcare

Application process

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team at +49 (0) (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 HireRight. You will be informed accordingly by your BioNTech-Recruiter.

Inspiration and equity

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragement, and creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other characteristic. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.