BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Statistical analyses for method development, validation, and stability of RNA therapeutics. 7+ years pharma/biotech experience, ideally RNA therapeutics, required. Flexible hours, vacation account.
Requirements
- 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 (Minitab, JMP)
- Analytical mindset with ability to independently design, execute, and evaluate statistical analyses
- Excellent communication skills (German and English)
Tasks
- Develop and implement statistical guidelines for method development
- Apply DoE and design space approaches per ICH guidelines
- Perform statistical analyses for method development and validation
- Conduct statistical analyses for stability studies and comparability assessments
- Perform statistical analyses for regulatory filings
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results
- Analyze stability studies and shelf-life data
- Perform trend modeling and estimate product shelf-life
- Prepare high-quality statistical data packages for regulatory submissions
- Respond to regulatory queries regarding statistical data
- Provide statistical training to enhance organizational capabilities
- Stay updated on advancements in the statistical field
Work Experience
- 7 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Minitab
- JMP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Statistical analyses for method development, validation, and stability of RNA therapeutics. 7+ years pharma/biotech experience, ideally RNA therapeutics, required. Flexible hours, vacation account.
Requirements
- 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 (Minitab, JMP)
- Analytical mindset with ability to independently design, execute, and evaluate statistical analyses
- Excellent communication skills (German and English)
Tasks
- Develop and implement statistical guidelines for method development
- Apply DoE and design space approaches per ICH guidelines
- Perform statistical analyses for method development and validation
- Conduct statistical analyses for stability studies and comparability assessments
- Perform statistical analyses for regulatory filings
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results
- Analyze stability studies and shelf-life data
- Perform trend modeling and estimate product shelf-life
- Prepare high-quality statistical data packages for regulatory submissions
- Respond to regulatory queries regarding statistical data
- Provide statistical training to enhance organizational capabilities
- Stay updated on advancements in the statistical field
Work Experience
- 7 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Minitab
- JMP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
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