Lead Statistician - Clinical Trials M/F/D

Les missions du poste

Qui sommes-nous ?
Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France.

Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.

Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue d’utilité publique, et secondairement par ses collaborateurs à travers un plan d’actionnariat salarié.

En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau « Excellence ».

Pierre Fabre est reconnu comme l’un des « Meilleurs Employeurs du Monde 2021 » par Forbes. Notre groupe est classé dans le Top 6 de l’industrie cosmétique et dans le Top 7 de l’industrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font préserver notre indépendance et vivre notre raison d'être.

Votre mission
The Biometry Department, part of the Data Science & Biometry Department at Pierre Fabre, supports all drugs being developed by the company.

The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.

We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department. This position requires a strong expertise in the application of statistics within the context of clinical trials, including Randomized Controlled Trials (RCTs).

The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in Randomized Controlled Trials is a must, the successful candidate will also contribute to Real World Evidence (RWE) studies.

Key Responsibilities:
- Participate in the conception and design of Randomized Controlled Trials, providing expert statistical support including study design, sample size determination, definition of study objectives and Estimates, writing the statistical section of the protocol and development of the statistical analysis plan.
- Act as the primary point of contact internally and externally for all statistical aspects of assigned projects and studies, attending project/study meetings and offering statistical guidance.
- Contribute to the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals.
- Draft and/or validate key study documents such as synopses, protocols, CRFs, data review plans, statistical analysis plans, statistical results, study reports and other study-level documents while ensuring timely deliverables.
- Program and/or validate statistical analyses using SAS software
- Collaborate with clinicians to interpret results, develop key messages, and communicate findings to clinical and regulatory partners.
- Work with clinicians and medical writers to prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / …), summaries of results for regulatory documents and scientific articles.
- Oversee the review of statistical documents within the team and supervise operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements.
- Participate in the strategy of submission dossier to FDA and EMA.
- Coordinate production of Safety and Efficacy integrated pool and related statistical analyses
- Follow all industry standards, including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF).

Qui êtes-vous ?
Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field.
- A minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO), with significant involvement in clinical trial development from the outset.
- Strong experience in oncology clinical trials.
- Advanced statistical analysis skills
- Proficiency in at least one of the following two statistical software: SAS or R
- Strong understanding of clinical trial design and methodology with substantial knowledge in at least of the following: Bayesian, Adaptive Designs, Basket / Umbrella / Platform Trial, Multiple-Testing Adjustment, Small Populations, Individualized Treatment Effects
- Strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).
- Excellent written and verbal communication skills in English
- Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
- Creativity, proactivity, rigor, autonomy, and collaborative spirit.
- Strong ability to manage multiple studies simultaneously and maintain organization.

Optional Skills
- Experience with real world evidence (RWE) studies
- Familiarity with CDISC standards
- Familiarity with machine learning techniques
- Familiarity with biomarker data and its applications in randomized controlled trials designs

Application Process

Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.

The hiring manager is Florence Carrère, Biometry Manager.

The Head of the Biometry Department is Guillaume Desachy.

We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.
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Le Département Biométrie (qui fait partie du Département Data Science & Biométrie) de Pierre Fabre recrute en CDI à Toulouse (site Langlade) ou Boulogne un(e) Lead Statistician pour les essais cliniques. Vous participerez, en autres, au design des études cliniques contrôlés randomisés et à la soumission des dossiers aux autorités de santé tout en supervisant les CROs de votre périmètre.

Une expérience de 6 ans minimum en industrie pharmaceutique et en CRO, avec une implication significative dans le développement des études cliniques interventionnelles en Oncologie et la supervision de CRO sont nécessaires pour la tenue du poste.
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Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction.