We are seeking a CMC Statistician to join a dynamic CMC team on a 12‐month consultancy basis. Extension possible depending on budget and performance. Freelancer or employee status possible. This role has been created to support increased workload across both development and commercial activities, including analytical work for gene therapy and one commercial product.
Key Responsibilities
* Manage diverse internal statistical requests aligned with team priorities
* Perform Design of Experiments (DoE) to optimize processes
* Conduct statistical analyses for development and quality control (bioassays, USP guidelines)
* Program statistical models (primarily in R, with some SAS during transition)
* Prepare clear, concise reports in English
* Collaborate with internal clients and cross‐functional teams
Must-Have Qualifications
* Strong statistical expertise, including mixed models
* Proficiency in R programming (mandatory)
* Solid knowledge of Design of Experiments (DoE)
* Fluent English (written and spoken)
* Master's degree in Statistics (minimum requirement)
Nice-to-Have Skills
* Experience in pharma / CMC environments
* Knowledge of bioassays and USP guidelines (1032, 1033, 1034)
* Familiarity with stability studies (ICH)
* PhD in Statistics (preferred but not required)
* French language skills (to ease integration)
* SAS programming knowledge (for transition)