CMC Statistician (Biologics Early Development)

MSI Pharma; Belgique; Vor Ort; USD 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical company is seeking an experienced CMC Statistician in a hybrid role to support innovative products in gene therapy and biologics. The ideal candidate will have a Master’s degree in Statistics, strong statistical expertise, and proficiency in R programming. Responsibilities include performing Design of Experiments, conducting statistical analyses, and preparing technical reports. This opportunity offers a flexible work environment and the potential for extension beyond the initial assignment of 12 months.

Qualifikationen

• Master’s degree in Statistics or higher.
• Strong statistical expertise, especially in mixed models.
• Proficient in R programming.

Aufgaben

• Perform Design of Experiments (DoE) for method development.
• Conduct statistical analyses for bioassays and QC activities.
• Deliver high-quality R-based statistical programming.
• Prepare clear technical reports in English.
• Collaborate with a team of statisticians and scientists.

Kenntnisse

Statistical expertise

R programming

Mixed models

Design of Experiments (DoE)

Fluency in English

Ausbildung

Master’s degree in Statistics

Tools

R

SAS

Jobbeschreibung

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.