Medical Affairs and HEOR Biostatistics Project Lead

About the role

We are looking for a Medical Affairs and HEOR Biostatistics Project Lead to join our Global Biometrics department at Servier. The role will drive methodological and statistical strategies for Medical Affairs and Health Economics and Outcomes Research (HEOR) evidence generation, shaping Integrated Evidence Generation Plans and supporting Joint Clinical Assessment dossiers.

Key responsibilities

• Lead the design and implementation of statistical approaches for Medical Affairs and HEOR across assigned products.
• Provide statistical leadership for Joint Scientific Consultations, value dossiers and payer submissions, ensuring compliance with EU HTA regulations.
• Author and review Statistical Analysis Plans (SAPs) and oversee analyses for post‑marketing, retrospective and observational studies.
• Monitor evolving HTA requirements, recommend methodological adjustments and ensure scientific robustness of protocols, reports and publications.
• Represent Biostatistics in cross‑functional teams, guide CROs and external vendors, and manage project resources and timelines.

Required profile

• Master’s or Doctoral degree in Biostatistics, Statistics or a related field.
• Minimum 5 years of experience supporting clinical development, Medical Affairs and HEOR evidence generation.
• Strong knowledge of real‑world evidence, indirect treatment comparisons and HTA frameworks (EU‑HTA, ISPOR).
• Proficiency with regulatory guidelines (ICH, FDA, EMA) and ability to communicate statistical concepts to non‑technical audiences.
• Fluency in English (oral and written) and experience in oncology is preferred.

Required skills

• Proficiency in SAS and R for statistical programming.
• Expertise in statistical analysis planning and execution of SAPs.
• Hands‑on experience with HTA methodologies, real‑world evidence analysis and indirect treatment comparisons.