Data Scientist - Statistician - CMC H / F

Astek; Lyon; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A CRO company is recruiting a Senior Preclinical Biostatistician in Lyon, France. The ideal candidate will have a Master's degree in Data Science and at least 7 years of experience in applied data science. Responsibilities include performing statistical analyses, ensuring regulatory compliance, and collaborating with teams. The role offers the opportunity to work on innovative projects in a supportive environment.

Qualifications

• 7+ years in applied data science/statistics, particularly in CMC-related projects.
• Strong expertise in statistics and machine learning.
• Familiarity with FDA, GMP, and ISO standards.

Responsabilités

• Perform statistical analyses and machine learning modeling in a CMC context.
• Ensure compliance with regulatory standards.
• Collaborate with multidisciplinary teams.

Connaissances

Statistical analyses

Machine learning modeling

Collaboration

Regulatory compliance

Formation

Master's degree in Data Science or Applied Statistics

Description du poste

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.

Your mission (should you decide to accept it)

As part of the Data Science and Innovation team, and in close collaboration with internal scientific experts, you'll work on high-impact assignments where data science meets CMC and regulatory challenges.

Your daily activities

Your work may include :

• Performing statistical analyses and machine learning modeling in a CMC context
• Establishing interpretation thresholds based on experimental data
• Supporting verification and validation phases of diagnostic products
• Ensuring compliance with regulatory standards (FDA, GMP, ISO)
• Collaborating with multidisciplinary teams and contributing to project documentation

Your future team

Join a CRO where data science is a core pillar of innovation. You'll evolve in a collaborative and agile environment, with freedom to explore new approaches and tools, and with access to a wide variety of scientific datasets across pharma, dermo-cosmetics, and biotech.

You

• Master's degree in Data Science or Applied Statistics
• Experience: 7+ years in applied data science / statistics, with proven experience in CMC‑related projects
• Strong expertise in statistics and machine learning
• Hands‑on experience with diagnostic data, especially immunoassays
• Solid understanding of CMC processes and regulatory expectations
• Familiarity with FDA, GMP, and ISO standards