Biostatistician | Biostatistiker* (m/w/d)
Rheacell GmbH & Co. KG
Job Summary
As a Biostatistician at RHEACELL, a leading biopharmaceutical stem cell company in Heidelberg, you will play a pivotal role in the development of innovative stem cell therapies for rare and inflammatory diseases. Your day-to-day responsibilities involve analyzing and interpreting clinical trial data (specifically Phase III), developing statistical analysis plans (SAPs), and conducting power analyses. You will work closely with interdisciplinary teams in Clinical Science and Regulatory Affairs to ensure scientific rigor and regulatory compliance with EMA and FDA guidelines. This role is particularly attractive as it offers the chance to work on 'game-changing' ATMP (Advanced Therapy Medicinal Products) currently in late-stage clinical trials. You will be instrumental in strengthening the biostatistics department, managing external CROs, and applying advanced data science to improve drug development decision-making processes in a highly specialized, scientific environment.
Required Skills
Education
University degree in Statistics, Biostatistics, or Mathematical Statistics.
Experience
- Professional experience in innovative statistical solutions within a clinical development environment
- Proven experience in the design, analysis, and interpretation of clinical trials and study programs
- Professional proficiency in R and SAS programming for statistical analysis
- Experience in immunology, inflammation, or rare diseases is preferred
- Experience in managing external service providers and Contract Research Organizations (CROs)
Languages
Additional
- The position is based in Heidelberg, Germany. Candidates must be able to work within global regulatory frameworks such as ICH-GCP, EMA, and FDA guidelines. Experience with ATMPs (Advanced Therapy Medicinal Products) or stem cell therapies is a plus.
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