As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

• Develop and improve biostatistical processes and standards related to clinical trials
• Represent GBS in cross functional process development teams to develop the optimal strategies to improve BioNTech’s efficiency, to build infrastructure with increased modernization and digitalization
• Lead GBS process development initiatives to develop the optimal strategies to improve GBS efficiency
• Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines
• Drive biostatistics strategy in accordance with company objectives
• Continuously monitor process efficiency and effectiveness, identify process improvement opportunities, and cooperate with stakeholders to scope and ensure alignment with strategic priorities
• Evaluate quality measure analysis including performance development and reporting, and provide recommendations to the GBS leadership team

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• At least 15 years of experience in the pharmaceutical/biotech industry in a relevant field such as Biostatistics
• At least 5 years functional and/or disciplinary leadership experience with convincing track record of leading team
• Excellent understanding of the drug development process with relevant experience in statistics and statistical programming is a must-meet criteria
• Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives
• Demonstrated experience with project management and application of operational excellence concepts
• Experience working with external parties and leading cross-functional teams
• High proficiency of English language (written and spoken), German is a plus