Medical Affairs and HEOR Biostatistics Project Lead

We are looking for a Medical Affairs and HEOR Biostatistics Project Lead. Due to the company’s international focus, this position is assigned to our head office in France, but can be based at our Munich office.

Key responsibilities:

• Proposes and leads the implementation of the methodological and statistical approaches for Medical Affairs and HEOR evidence generation plans across assigned products, while ensuring alignment with medical, regulatory, and market access objectives.
• Provide statistical leadership for Integrated Evidence Generation Plans (IEGP), Joint Scientific Consultations (JSC), and Joint Clinical Assessment (JCA) dossiers.
• Collaborate with HEOR partners and contribute clinical evidence to value dossiers and payer submissions, ensuring alignment with EU HTA Regulation requirements and other payer expectations.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to fill the evidence gaps.
• Monitor evolving HTA requirements, regulatory guidance, and industry standards ; recommend adjustments to internal practices to ensure compliance and competitiveness.
• Provide statistical leadership for HTA-related analyses, post-marketing studies, retrospective and observational studies, registry studies, indirect treatment comparisons, and patient-reported outcome research.
• Author and review statistical analysis plans (SAPs), including table, listing, and figure (TLF) shells. Oversee execution of statistical analyses, ensuring methodological rigor, quality control, and appropriate interpretation of results.
• Review protocols, study reports, briefing materials, and publications to ensure scientific robustness and consistency.
• Represent Biostatistics on cross-functional medical and evidence generation teams, influencing decision-making by clearly articulating statistical perspectives.
• Support regulatory and payer interactions involving real-world evidence or outcomes-based data packages, including responding to statistical inquiries.
• Is responsible for monitoring statistical activities across projects, participates in estimating necessary resources with his/her superiors, is responsible for adherence of these resources and planning the studies, and offers scenarios for any identified shortfall.
• Provide oversight of CROs and external statistical vendors to ensure adherence to methodological standards and regulatory expectations.
• Coordinates or contributes to departmental process improvement initiatives and development/revision of SOPs.
• Support publication strategy through statistical review of abstracts, posters, and manuscripts.
• Provide guidance and support interpretation of statistical findings to internal stakeholders and external experts.

Qualifications:

• Master or Doctoral degree or equivalents in Biostatistics, Statistics or closely related fileds.
• Several years’ experience as statistician supporting clinical development, Medical Affairs, and HEOR evidence generation.
• Strong knowledge of real-world evidence, post-approval studies, indirect treatment comparisons, and HTA-related submissions.
• Mastery of (ICH, FDA, EMA) and HTA frameworks (e.g., EU-HTA, ISPOR).
• Proficiency in SAS and R.
• Experience contributing statistical inputs to regulatory or payer interactions strongly preferred.
• Demonstrated ability to independently determine appropriate study designs and analytical strategies.
• Ability to respond to regulatory or external inquiries.
• Oncology experience is preferred.
• English fluency is required.
• Proven ability to manage CRO partnerships and ensure adherence to best practices.
• Demonstrated sound judgment and decision-making, with…