Statistical Expert CMC - Analytical Development

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.

Requirements

• Advanced degree in statistics, mathematics, or related field (PhD or Master’s preferred)
• Proven experience in pharma/biotech analytical development (5+ 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

• Flexible hours
• Vacation account
• Digital Learning
• Performance & talent development
• Leadership development
• Apprenticeships
• LinkedIn Learning
• Company bike
• Job ticket
• Deutschlandticket
• Employer-funded pension
• Childcare