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:
Location:
Pratteln, Switzerland (Hybrid)
Scope of Work
As Head of Biostatistics, you will lead the Biostatistics team, provide statistical and data expertise to the Program Team, and ensure the proper implementation of statistical methodologies in Santhera’s drug development programs, including clinical development, global registration, market access, medical marketing, and lifecycle management. This role reports to the Head of Development.
Key Responsibilities
1. Ensure appropriate statistical methodologies are used in the assigned development programs.
2. Manage the Biostatistics team, including statisticians, statistical programmers, and data management staff.
3. Act as Program Statistician in the Global Program Team.
4. Define outsourcing strategies for biostatistics activities and oversee their execution.
5. Review and approve study-level documents (e.g., protocols, analysis plans, reports) and project-level documents (e.g., development plans).
6. Contribute to regulatory strategies for global submissions.
7. Participate in global meetings and interactions with regulatory authorities as an expert statistician.
8. Review relevant sections of regulatory submissions.
9. Develop processes and SOPs related to statistical programming and analysis.
10. Collaborate within a matrix organization with development and commercial teams.
Required Qualifications & Experience
* M.Sc. or higher in statistics or life sciences.
* At least 10 years of professional experience as a clinical data analyst/statistician in pharma or CRO.
* Minimum 5 years of people management experience.
* Experience in global regulatory interactions.
* Experience supporting market access, medical marketing, and lifecycle management.
* Expertise in designing clinical studies, authoring statistical documents, and regulatory submissions.
* Thorough understanding of statistical methods in clinical development and ability to implement novel methodologies.
* Excellent written and spoken English skills.
* Legal authorization to work in Switzerland/EU or Swiss/EU citizenship is required.
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare neuromuscular diseases with high unmet medical needs. For more information, visit www.santhera.com.
If interested in a multicultural, challenging, and innovative environment, and if your profile matches our requirements, please submit your application in English via LinkedIn or email to career@santhera.com. No recruitment agencies, please.
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