Gif-sur-Yvette, France.
Are you a strategic and methodological expert passionate about bridging the gap between clinical data, medical affairs, and global market access? We are seeking a Medical Affairs and HEOR Biostatistics Project Lead to join our Global Biometrics department in our Suresnes (HQ) and/or Saclay (R&D) site. This is a unique opportunity to lead the methodological and statistical strategy for Medical Affairs and Health Economics and Outcomes Research (HEOR) evidence generation plans. Your work will be pivotal in shaping Integrated Evidence Generation Plans (IEGP) and securing successful Joint Clinical Assessment (JCA) dossiers, directly impacting how our innovative treatments reach patients and payers worldwide.
Why Join Us?
- Impactful Evidence Generation: You will be at the heart of value demonstration. By leading statistical leadership for HTA-related analyses and indirect treatment comparisons, you provide the critical evidence that payers and regulatory bodies need to evaluate the therapeutic value of our pipeline.
- Innovative Methodology: Work in a dynamic environment where you are encouraged to identify and adapt optimal statistical research methodologies. You will fill evidence gaps using innovative approaches in real-world evidence, registry studies, and patient-reported outcomes research.
- Collaborative & Strategic Leadership: Join an international matrix environment. You will represent Biostatistics on cross-functional medical teams, influence decision-making, and provide oversight of external partners (CROs) to ensure the highest standards of methodological rigor and scientific robustness.
Responsibilities:
- 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.
Profile:
- 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.
This job is posted by Servier.
This link brings you to the website of Servier.
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