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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.
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:
Scope of Work
As the Head of Biostatistics, you will be a key leader in our growing biotechnology company, responsible for shaping and executing the statistical strategy across our Clinical Development, Regulatory Affairs, Medical Affairs and Medical-Marketing functions. You will lead a multi-disciplinary Biostatistics Department, including statisticians, data managers, and programmers, while ensuring the seamless integration of external vendors and contract research organizations (CROs). This role provides a unique opportunity to make a high impact in a dynamic, fast-paced environment focused on rare diseases in a company with ambitions for growth.
You will oversee all statistical aspects of clinical trials and real-world evidence (RWE) studies, ensuring scientific rigor, efficiency, and regulatory compliance. Your role will balance strategic leadership with hands-on expertise, fostering a high-performance team that is data-driven and outcome-focused.
Key Responsibilities
* Define and implement the statistical strategy supporting clinical development and real-world evidence (RWE)studies and initiatives.
* Assess and optimize the departmental structure, workflows, and resourcing to ensure efficiency and timely execution of statistical deliverables.
* Act as the strategic statistical lead for clinical programs, regulatory submissions, and cross-functional collaborations.
* Recruit, retain and mentor talent
Operational Oversight
* Provide line management, mentorship, and technical guidance to biostatisticians, data managers, and programmers.
* Oversee external vendors and ensure quality delivery of outsourced statistical activities.
* Ensure seamless integration of statistical deliverables with clinical and regulatory strategies.
Scientific & Technical Excellence
* Lead the development and review of Statistical Analysis Plans (SAPs), study concepts, study protocols, and regulatory documents.
* Provide expertise in advanced statistical methodologies, including Bayesian modelling, mixed models, and adaptive trial designs.
* Ensure statistical integrity in clinical trials with small sample sizes, typical of rare disease drug development.
* Experienced in using SAS
Regulatory & Compliance
* Represent the company in global regulatory interactions, including FDA, EMA, and other health authorities.
* Contribute to regulatory filings, including NDA/BLA submissions, briefing documents, and responses to agency queries.
* Stay ahead of industry trends and evolving statistical methodologies in drug development.
Budget & Resource Management
* Develop and maintain departmental forecast and resource plan, ensuring alignment with project goals, timelines and financial targets.
* Optimize resource allocation between in-house and outsourced statistical activities.
Required Background and Experience
* MSc or PhD in Statistics, Biostatistics, or a related field.
* 10+ years of experience in clinical biostatistics, with significant exposure to rare diseases, real-world evidence, and regulatory submissions.
* 5+ years of leadership or cross functional matrix experience, with a proven track record of managing and developing or working within high-performing teams.
* Extensive experience in designing clinical studies, including adaptive designs and Bayesian methods; Regulatory submissions, including NDA/BLA filings and regulatory agency interactions; Advanced statistical modelling, including longitudinal and mixed models; Real-world data analysis and evidence generation strategies; Strong knowledge of GCP, ICH guidelines, and CDISC standards (SDTM, ADaM).
* Excellent communication skills, with the ability to translate complex statistical concepts into actionable insights for cross-functional teams.
* Solution-oriented, proactive, and adaptable in dynamic situations.
* Fluency in English (additional languages are a plus).
For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.
If you are interested in a multicultural, challenging, and innovative working environment and your profile matches our requirements, we are looking forward to receiving your online application in English via LinkedIn or Email, at career@santhera.com
Note for agencies: Recruitment agencies are kindly invited to refrain from sending unsolicited CVs to Santhera.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Analyst, Science, and Engineering
* Industries
Pharmaceutical Manufacturing
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