Biostatistician - Clinical Trials, Statistical Programming (m/f/d)

BioNTech SE

Berufsfeld
Technik

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Biostatistician - Clinical Trials, Statistical Programming (m/f/d), BioNTech SE

Become a member of the BioNTech Family! 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. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. (Senior) Director Biostatistics Process Excellence 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 BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Click here to find out more about what we do, the careers we offer and also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

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