Senior Biostatistician
Key information
- Publication date:09 October 2025
- Workload:100%
- Contract type:Unlimited employment
- Place of work:Pratteln
Job summary
Santhera Pharmaceuticals is a Swiss specialty company focused on rare neuromuscular diseases. Join our team to impact patients' lives through innovative treatments!
Tasks
- Lead statistical design and analysis of clinical trials and RWE.
- Collaborate with cross-functional teams and external partners.
- Ensure regulatory compliance and high-quality statistical deliverables.
Skills
- MSc/PhD in Statistics or Biostatistics, 8+ years experience.
- Strong communication and collaboration skills required.
- Proficiency in SAS and advanced statistical modeling.
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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.
- 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.
- 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.
- MSc or PhD in Statistics, Biostatistics, or a related field.
- Minimum 8 years of experience in clinical biostatistics within the pharmaceutical/biotech industry or CROs.
- Strong background in clinical trial design, and advanced statistical modelling.
- Experience in contributing to regulatory submissions and interactions with health authorities.
- Experience with real-world evidence analyses and strategies.
- Experience in applying statistical methods in post-approval stage.
- Solid knowledge of ICH guidelines, and CDISC standards (SDTM, ADaM).
- Proficiency in SAS.
- Previous leadership or mentoring experience advantageous.
- Excellent communication skills, with the ability to present complex statistical concepts to non-statistical audiences.
- Detail-oriented, solution-focused, and adaptable in a dynamic environment.
- Strong collaboration skills, with experience working in cross-functional teams.
- Fluency in English (other languages are an advantage).
