As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project "Lightspeed" based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
The aim is to achieve life-changing successes for patients by being innovative, passionate and united, so 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.
You will be responsible for the implementation of mathematical concepts and statistical models in clinical research projects as well as participation in strategy and team development. Your duties in detail:
- 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 support TLF development
- Perform statistical analyses and validate analysis results
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality in a timely manner
- Develop, implement and improve statistical processes and standards (SOPs)
- Support and participate in the development of departmental strategies
- Provide support and day-to-day team development as a subject-matter-expert (SME)
What you have to offer.
- University degree (MSc/PhD) in statistics or mathematics and at least 10 years of relevant experience in biostatistics in pharmaceutical industry and/or CRO
- Experience with clinical drug development and clinical trials in oncology and excellent knowledge of clinical study designs and statistical methods
- Knowledge in innovative adaptive designs is desired as well as excellent knowledge of relevant regulatory guidelines (ICH, FDA, EMA)
- Adaptability to rapidly changing organizational and business environment; Awareness of the bigger picture and innovative and solution orientated thinking
- Attention to detail with a strong orientation to quality, fluent English language skills and very good oral and written communication skills required; Ability to communicate fluently in German highly preferred
- Experience with SAS required; EAST software experience preferred
- Experience with regulatory/governmental registrations and submissions preferred
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation