Biostatistician - Clinical Studies, Statistical Analysis (m/f/d)

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

Job Description:

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 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 Open for hire at one of the following locations - Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. PhD or Masters in Statistics or Biostatistics 10+ 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 Cell Gene Therapies (CAR-T, iNEST) 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.

Keywords: BioNTech SE, Cambridge , Biostatistician - Clinical Studies, Statistical Analysis (m/f/d), Healthcare , Cambridge, Massachusetts