Senior Biometrics Transformation Lead (M/W)

About the role

Pierre Fabre Laboratories, a global pharma and dermo-cosmetics company, is looking for a senior, highly experienced biometrics transformation lead to join its Data Science and Biometrics (DS&B) group. The role leads the transformation of the biometrics operating model, combining technical credibility in biometrics with the ability to drive cross-functional change, strengthen internal ownership and control over study and submission deliverables. It is based in Toulouse with flexible commuting options.

Key responsibilities

• Lead the biometrics transformation roadmap, turning strategic priorities into operating model changes, governance, processes and measurable outcomes.
• Strengthen oversight of statistical strategy, statistical programming, TFL delivery, data management, quality control and submission outputs.
• Prioritise competing initiatives and define governance mechanisms to improve delivery predictability from FIH through registrational studies.
• Support internalisation or reinforced oversight of high-value activities such as statistical programming and data flow.
• Champion CDISC SDTM/ADaM, USDM, SAS and R/Posit, and automation/GenAI in a GxP-compliant way.
• Set up RACI models and ways of working with CROs, Clinical Development, Medical Writing, Clinical Operations, Regulatory Affairs, Quality Assurance and R&D IT.
• Monitor transformation KPIs and provide executive updates, risk assessments and recommendations to DS&B and R&D leadership.

Required profile

• Advanced degree (preferably MSc or PhD) in Statistics, Biostatistics or Statistical Programming.
• 10+ years in pharma or biotech R&D, as lead statistician, statistical programming lead or biometrics team lead.
• Leadership in FIH/early and pivotal studies, with CRO and regulatory stakeholder interaction.
• Experience overseeing statistical programming, outsourced biometrics and improving CRO governance.
• Consulting, transformation, operational excellence or program management experience; fluency in English and French.
• A plus: experience in oncology, dermatology or rare diseases.

Required skills

• CDISC SDTM and ADaM, SAS and R/Posit
• GxP compliance and knowledge of automation and GenAI in clinical development

What we offer

• Incentives, profit-sharing and shareholding with matching contribution
• Health and provident insurance
• 16 days of RTT holidays plus 25 days of personal leave
• Public transport participation