Career Opportunity: Contribute to Treatment Options for Rare Diseases
Make a difference in the lives of children and adults affected by severe rare diseases. As our new Head of Biostatistics, you will lead a team and provide statistical expertise to support drug development.
Scope of Work
Lead the Biostatistics team, providing Statistical and Data expertise to the Program Team. Ensure the adequate implementation of statistical methodology across Santhera's drug development program, including clinical development, global registration, market access, medical marketing, and life-cycle management.
Key Responsibilities
* Implement appropriate statistical methodology in assigned development programs.
* Manage a team of statisticians, statistical programmers, and data managers.
* Act as a Program Statistician in the Global Program Team.
* Determine outsourcing strategies for biostats activities and ensure oversight.
* Review and approve study-level documents, such as clinical study protocols and statistical analysis plans.
* Contribute to regulatory strategy for global submissions.
* Participate in global meetings with regulatory authorities as an expert statistician.
* Develop processes and standard operating procedures related to statistical programming and statistics.
* Collaborate with development and commercial teams.
Required Qualifications & Experience
* M.Sc. degree or higher in Statistics or Life Sciences.
* At least 10 years of experience as a clinical data analyst/statistician in a pharmaceutical company or CRO.
* Minimum 5 years of people management experience.
* Experience in global regulatory interactions.
* Expertise in designing clinical studies, authoring statistical sections, and reviewing clinical trial reports.
* Thorough understanding of statistical methods used in clinical development.
* Outstanding written and spoken English skills.
This position requires a valid working/residency permit or Swiss/EU citizenship.
We are a multicultural, challenging, and innovative working environment. If your profile matches our requirements, we look forward to receiving your online application in English via LinkedIn.