CMC Statistician

il y a 4 semaines


Mons, Belgique Hays Temps plein

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 ResponsibilitiesManage diverse internal statistical requests aligned with team prioritiesPerform Design of Experiments (DoE) to optimize processesConduct 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 EnglishCollaborate with internal clients and cross‐functional teamsMust-Have QualificationsStrong statistical expertise, including mixed modelsProficiency 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 SkillsExperience in pharma / CMC environmentsKnowledge 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)