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MSI Pharma

CMC Statistician (Biologics Early Development)

town of belgium, WI

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About this opportunity

MSI Pharma lists this CMC Statistician (Biologics Early Development) opportunity in town of belgium, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.

Job description

CMC Statistician (Biologics Early Development) Location: Braine-l’Alleud, Belgium (Hybrid – min. 40% on-site) Start Date: February 2026 (Minimum 1-year duration)

We are seeking a skilled CMC Statistician to join a growing team within a leading biopharmaceutical company based in Braine-l’Alleud. Due to increased workload across both development and commercial CMC activities, the organisation is expanding its statistical capabilities for 2026. This is an excellent opportunity to work within the “Biologics Early Development” group, supporting innovative products in gene therapy, biologics, and one established commercial asset.

About the Role

As a CMC Statistician, you will support a wide range of internal statistical requests, driven by organisational priorities and project needs. You will work closely with scientists, analytical development teams, quality teams, and other internal stakeholders to deliver high-quality statistical support across development and quality control activities.

Key responsibilities include:

Performing Design of Experiments (DoE) to support method development and process optimisation

Conducting statistical analyses for bioassays and QC-related activities, in line with USP guidelines

Delivering high-quality R-based statistical programming (SAS exposure beneficial for transition)

Preparing clear, well-structured technical reports in English

Collaborating cross-functionally within a team of 14 statisticians and scientists

Profile – Must Have

Master’s degree in Statistics (minimum)

Strong statistical expertise, including mixed models

Proficiency in R programming

Knowledge of DoE

Fluent in English (written and spoken)

Nice to Have

Pharma/CMC experience

Knowledge of bioassays and USP 1032/1033/1034

Familiarity with ICH stability studies

PhD degree

French language skills (advantage for integration)

SAS knowledge

Work Environment

Hybrid model: minimum 40% on-site (typically Tuesdays and Thursdays)

Flexible scheduling based on meetings and project demands

This 12-month assignment has a strong likelihood of extension, depending on performance and budget.

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