Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused
on medical science and the development and commercialization of innovative
pharmaceutical products for the treatment of rare neuromuscular diseases with
high unmet medical need. For further information, please visit the company's
website www.santhera.com
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe
impact on the lives of affected children and adults. You can make a difference as:
Senior Biostatistician
Location: Pratteln, Switzerland (Hybrid)
Overview
As a Senior Biostatistician, you will play a critical role in supporting clinical development and real-world evidence
(RWE) initiatives. You will be responsible for the statistical design, analysis, and interpretation of clinical trials and
observational studies, ensuring scientific rigor, regulatory compliance, and high-quality deliverables.
This role is hands-on and highly collaborative, working closely with colleagues across clinical science, clinical
operations, data management, statistical programming, regulatory, and medical affairs, as well as with external
vendors and CROs. This position reports to the Head of Clinical Operations and offers an excellent opportunity to
contribute to the advancement of innovative therapies within a dynamic and multicultural environment.
Key Responsibilities
Scientific & Technical Excellence
- Contribute to the design and statistical methodology of clinical trials and RWE studies.
- Develop and review Statistical Analysis Plans (SAPs), study protocols, and clinical/regulatory documents.
- Perform and oversee statistical analyses, ensuring accuracy, reproducibility, and regulatory compliance.
- Apply statistical methods (e.g., mixed models for longitudinal data, time-to-event analyses, methods for
matching with external datasets) with a focus on rare disease development.
- Ensure statistical integrity in studies with small sample sizes.
- Proficiently use SAS for programming and analysis.
Operational Support
- Collaborate with internal cross-functional teams (clinical science, clinical operations, regulatory, medical
affairs, data management, programming).
- Interact with CROs and external partners to ensure quality and consistency of outsourced statistical activities.
- Provide statistical input during study start-up, conduct, and reporting phases.
Regulatory & Compliance
- Contribute to statistical content for regulatory filings, including IND, NDA/BLA submissions, briefing packages,
safety reports, and responses to health authority questions.
- Support preparation for regulatory interactions (FDA, EMA, and other agencies).
- Stay current on evolving methodologies, regulatory requirements, and statistical best practices.
