Medical Affairs and HEOR Biostatistics Project Lead

Servier

Propose and lead the implementation of methodological and statistical approaches for Medical Affairs and HEOR evidence generation across assigned products.
Provide statistical leadership for Joint Scientific Consultations (JSC), value dossiers, and payer submissions, ensuring alignment with EU HTA Regulation requirements.
Author and review Statistical Analysis Plans (SAPs) and TLF shells, overseeing the execution of analyses for post-marketing, retrospective, and observational studies.
Monitor evolving HTA requirements and industry standards, recommending adjustments to internal practices to maintain competitiveness.
Review protocols, study reports, and publications to ensure scientific robustness and consistency across all evidence generation activities.
Represent Biostatistics in cross-functional teams, articulating statistical perspectives to influence strategic decision-making.
Support the publication strategy through the statistical review of abstracts, posters, and manuscripts.
Provide oversight of CROs and external vendors, ensuring adherence to methodological standards and regulatory expectations.
Manage resources and planning for assigned projects, offering scenarios for any identified shortfalls.

Master’s or Doctoral degree (or equivalent) in Biostatistics, Statistics, or a closely related field.
At least 8 years of experience as a statistician supporting clinical development, Medical Affairs, and HEOR evidence generation.
Strong knowledge of real-world evidence (RWE), indirect treatment comparisons (ITC), and HTA frameworks (e.g., EU-HTA, ISPOR).
Mastery of regulatory guidelines (ICH, FDA, EMA) and proficiency in SAS and R.
Demonstrated ability to independently determine appropriate study designs and analytical strategies for complex evidence packages.
Proven ability to manage CRO partnerships and provide guidance to non-statistical audiences.
Excellent communication skills with a detail-oriented and well-organized approach to managing multiple projects.
Experience in Oncology is preferred.
Fluency in English (oral and written) is mandatory.