Develop and implement statistical guidelines for method development and comparability studies, including Design of Experiments (DoE) and design space approaches aligned with ICH guidelines
Job Summary
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.
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
Matching Summary
Develop and implement statistical guidelines for method development and comparability studies, including Design of Experiments (DoE) and design space approaches aligned with ICH guidelines.
Skills & Requirements
Must-have
Develop statistical guidelines
Perform statistical analyses
Ensure regulatory compliance
Optimize method development workflows
Analyze stability and shelf-life data
Investigate OOS/OOT results
Nice-to-have
Contribute to regulatory filings
Enhance organizational capabilities
Stay updated on advancements
Key Requirements
Advanced degree in statistics, mathematics, or related field (PhD or Master’s preferred)
7+ years of experience in pharma/biotech analytical development
Strong knowledge of FDA, EMA, and ICH regulations for CMC processes
Proficiency in statistical software tools such as Minitab and JMP
Excellent communication skills (German and English)