Associate Director, Biostatistics

About the role

This is a permanent, hybrid position in Basel, Switzerland, within a Data Science department. You will take statistical ownership of an assigned clinical study, working closely with colleagues across Clinical Development, Biostatistics, Programming, Data Management and Regulatory. The role combines hands-on statistical work with contributions to late-stage development and regulatory submissions.

Key responsibilities

• Act as lead statistician for assigned clinical studies, contributing to study design, protocol development, sample size calculations and randomisation.
• Develop statistical analysis plans and perform or oversee analyses, ensuring accurate interpretation and reporting of clinical data.
• Review tables, listings and figures and contribute to clinical study reports, publications and presentations.
• Support regulatory submission packages, integrated analyses and responses to regulatory questions.
• Oversee external vendors and CRO partners, ensuring high-quality, timely and compliant statistical deliverables.
• Work closely with Clinical Development, Programming, Data Management and Regulatory colleagues on statistical methods and analytical processes.

Required profile

• Approximately 7-10 years of relevant pharmaceutical or biotechnology experience, including responsibility as a study statistician.
• A degree in Statistics, Biostatistics or a related discipline.
• Experience in late-stage clinical development and contributing to regulatory submission packages.

Required skills

• Strong knowledge of clinical trial statistical methods, including repeated measures, mixed models, categorical analyses and time-to-event methods.
• Strong statistical programming skills, particularly R, alongside knowledge of SAS.
• Familiarity with FDA, ICH and EMA guidance and CDISC standards.