Description
Associate Director, Biostatistics
Basel, Switzerland | Permanent | Hybrid
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.
This is an opportunity to take statistical ownership of an assigned clinical study, contribute to Phase III development and support future regulatory submissions within a collaborative Data Science department.
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, contributing to statistical methods and analytical processes.
Requirements
- 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.
- 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 relevant FDA, ICH and EMA guidance and CDISC standards.