Senior Biostatistician

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.

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:

Overview Senior Biostatistician role responsible for the statistical design, analysis, and interpretation of clinical trials and observational studies, ensuring scientific rigor, regulatory compliance, and high-quality deliverables. The position is hands-on and highly collaborative, working with clinical science, clinical operations, data management, statistical programming, regulatory, medical affairs, external vendors, and CROs. Reports to the Head of Clinical Operations and operates in a dynamic, multicultural environment.

Key Responsibilities

Scientific & Technical Excellence

Contribute to design and statistical methodology of clinical trials and RWE studies.

Develop and review Statistical Analysis Plans (SAPs), study protocols, and 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, 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 and interact with CROs/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 (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.

Required Qualifications & Experience

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 contributing to regulatory submissions and interactions with health authorities.

Experience with real-world evidence analyses and strategies.

Experience applying statistical methods in the post-approval stage.

Solid knowledge of ICH guidelines and CDISC standards (SDTM, ADaM).

Proficiency in SAS.

Leadership or mentoring experience is advantageous.

Excellent communication skills; ability to present complex statistical concepts to non-statistical audiences.

Detail-oriented, solution-focused, and adaptable in a dynamic environment.

Strong collaboration skills and experience working in cross-functional teams.

Fluency in English (other languages are an advantage).

For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.

If you are interested in a fast-paced, multicultural, challenging, and innovative working environment and your profile matches our requirements, we welcome your online application in English via LinkedIn or email at

Note for agencies:

Recruitment agencies are kindly invited to refrain from sending unsolicited CVs to Santhera.

Seniority level Mid-Senior level

Employment type Full-time

Job function Science

Industries Pharmaceutical Manufacturing

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