Summary

The Biometry Department at Pierre Fabre supports all drugs being developed by the company. The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.

We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92). This senior role is central to the safety oversight of clinical development programmes, with a particular emphasis on safety signal detection, benefit–risk evaluation, and regulatory compliance. The successful candidate will serve as the internal representative and process owner for clinical development safety, leading the harmonization and implementation of a company-wide safety signal detection framework, and working closely with the Head of Clinical Safety, Head of Clinical Development, Medical Directors, Data Managers, Statistical Programmers, and Statisticians.

About the role 

Key responsibilities:

• Lead the design and implementation of safety signal detection processes for clinical development programmes by providing expert statistical support, ensuring early identification and evaluation of emerging safety risks.
• Provide statistical leadership specific to safety on the entire Pierre Fabre R&D portfolio, contributing to the conception of Controlled Trials and safety analysis plan.
• Coordinate periodic safety reviews at the programme level, synthesising data from AEs, SAEs, and other relevant sources, and supporting relevant R&D stakeholders in benefit–risk assessments.
• Lead the development and maintenance of safety analytics reporting tools in partnership with relevant R&D stakeholders.
• Serve as the primary point of contact in the Biometry Department for safety-related matters on the entire Pierre Fabre R&D portfolio, providing expert guidance to internal and external stakeholders.
• Collaborate with clinicians, medical writers, and regulatory partners to interpret safety data and communicate findings effectively.
• Oversee the selection and management of CROs and external vendors for safety analytics and signal detection activities.
• Program and/or validate statistical analyses using SAS or R software.
• Ensure compliance with international regulatory guidelines (ICH, EMA, FDA) and internal procedures.
• Support the harmonization of safety processes across all clinical development programmes, including the deployment of pilot projects and the scaling of best practices.
• Represent Pierre Fabre in external clinical safety networks, working groups, and industry conferences to enhance the department’s visibility and reputation.

This position is compatible with teleworking up to 2 days a week according to company rules.

• Advanced expertise in safety signal detection, benefit–risk evaluation, and clinical trial methodology.
• Excellent knowledge of clinical safety processes and tools, including safety analytics and signal detection.
• Excellent knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).
• Excellent written and verbal communication skills in English
• Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
• Creativity, proactivity, rigor, autonomy, and collaborative spirit.
• Strong ability to manage multiple projects simultaneously and maintain organization.
• Strong analytical skills with the ability to provide recommendations and propose/implement effective solutions.
• Proficiency in at least one of the following two statistical software: SAS or R

How to Apply

To find out more and apply, please click here.