Biostatistician - Associate Director, Clinical Studies (m/f/d)

Company: BioNTech SE
Location: Cambridge
Posted on: November 16, 2023

Job Description:

Become a member of the BioNTech Family! As part of our team of more than 4,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards - by far the fastest vaccine development in the history of medicine. Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion. If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other! Associate Director Biostatistics Represent Statistics in cross-functional project and study teams in multiple projects Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables Perform sample size calculations, develop statistical analysis plans and lead TLF development Perform statistical analyses and validate analysis results Oversee outsourced statistical CRO activities and deliverables ensuring highest quality Develop, implement and improve statistical processes and standards Support and participate in the development of departmental strategies Interact with global regulatory authorities PhD or Masters in Statistics or Biostatistics 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking Preferred experience with clinical study designs in Oncology or Infectious Diseases BioNTech is committed to the wellbeing of our team members and offers a variety of benefits supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate's qualifications and experience. Please click the link below to review a highlight of our benefits -

Keywords: BioNTech SE, Cambridge , Biostatistician - Associate Director, Clinical Studies (m/f/d), Executive , Cambridge, Massachusetts