Senior Principal Biostatistician

Main Responsibilities

• Provide strategic and scientific leadership and statistical solutions with a high degree of autonomy.
• Provide statistical input to regulatory submissions, responses to authorities, and briefing documents.
• Serve as statistical lead and strategic partner for one or more therapeutic areas, ensuring statistical integrity and consistency across studies.
• Provide statistical leadership and input to the development of protocols, SAPs, and CSRs.
• Lead the design, analysis, and interpretation of clinical trials along with mentorning statisticians
• Own the quality and timeliness of statistical and programming deliverables.
• Ensure compliance with regulatory standards.
• Stay current on evolving regulatory guidance and methodological advances.
• Collaborate closely with clinical science, data management, medical writing, programming and regulatory teams to drive quantitative decision making in drug development.
• Influence decisions at program level.
• Defend statistical positions in internal and external meetings, including regulatory interactions.

• Relevant Swiss working / residency permit and / or Swiss / EU-Citizenship required;
• Bachelors, Masters degree of Phd in mathematics, statistics, data science, or related quantitative discipline.
• Atleast 10 years of extensive knowledge and expertise gained as a statistician or data scientist within the pharmaceutical industry
• 3 years of experience in a leadership or supervisory role
• Lead or key contributor to major regulatory submissions and successful interactions with FDA, EMA, or other health authorities
• Knowledge of international clinical research regulations and requirements, pharmaceutical industry and of the scientific, clinical, and regulatory components in the drug development process
• Proficiency in R
• Strong interpersonal skills and the ability to develop good working relationships with internal colleagues and external collaborators
• Ability to independently deal with complex and difficult situations, work under pressure, and prioritize tasks
• Active participation in industry working groups, standards bodies, or peer-reviewed publications / presentations
• Excellent communication and organizational skills