Lead Biostatistician
With a 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, you will be working to find the COVID-19 Vaccine our project. Furthermore, they're pioneers in the development of individualized cancer therapies and in the combat against other diseases.
With the aim to achieve life-changing successes for patients by being innovative, passionate and united, so get in touch if you are looking to be a part of creating hope for a healthy future in many peopleยดs 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) and participate in the development of departmental strategies
- Provide support and day-to-day team development as a subject-matter-expert (SME)
The requirements
- 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
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
