Senior MA and HEOR Biostatistician F​/M

Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation :
Engagés pour le progrès thérapeutique au bénéfice des patients.

Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.
Nous ? 22 000 passionnés de plus de 50 national ités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.
Venez vivre et contribuez à faire vivre notre engagement #Moved By You

We are seeking a Biostatistician to play a pivotal role in our Medical Affairs and Health Economics and Outcomes Research (HEOR) initiatives.

In this critical position, you will be instrumental in delivering robust statistical support for our evidence generation plans, ensuring scientific rigor and strategic alignment with medical, regulatory, and market access objectives. You will be at the forefront of contributing to value dossiers, payer submissions, and navigating the evolving landscape of HTA requirements.

• Provide expert statistical support for Medical Affairs and HEOR evidence generation plans across assigned products, ensuring alignment with medical, regulatory, and market access objectives.

• Serve as the primary Biostatistics representative for Integrated Evidence Generation Plans (IEGP), Joint Scientific Consultations (JSC), and Joint Clinical Assessment (JCA) dossiers.

• Collaborate closely with HEOR partners, contributing clinical evidence to value dossiers and payer submissions, with a keen focus on adherence to EU HTA Regulation requirements and other payer expectations.

• Champion the use of innovative statistical methodologies by identifying, adapting, developing, or applying optimal statistical research techniques to address evidence gaps.

• Continuously monitor evolving HTA requirements, regulatory guidance, and industry standards, recommending necessary adjustments to internal practices to maintain compliance and competitiveness.

• Offer comprehensive statistical support for HTA-related analyses, post-marketing studies, retrospective and observational studies, registry studies, indirect treatment comparisons, and patient-reported outcome research.

• Author and meticulously review Statistical Analysis Plans (SAPs), including table, listing, and figure (TLF) shells. Oversee the execution of statistical analyses, upholding methodological rigor, quality control, and appropriate interpretation of results.

• Review protocols, study reports, briefing materials, and publications to guarantee scientific robustness and consistency.

• Represent Biostatistics on cross-functional medical and evidence generation teams, influencing strategic decision-making through clear articulation of statistical perspectives.

• Support regulatory and payer interactions involving real-world evidence or outcomes-based data packages, including prompt responses to statistical inquiries.

• Provide robust oversight of Contract Research Organizations (CROs) and external statistical vendors, ensuring strict adherence to methodological standards and regulatory expectations.

• Coordinate or contribute significantly to departmental process improvement initiatives and the…