Lead Statistician – Real World Evidence -CDI- M/F

Qui sommes-nous ?

Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain! Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du "We Care Movement".

Your mission Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne. This position can be filled remotely. This position requires a strong expertise in the application of statistics within the context of Real-World Evidence studies. 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 RWE is a must, the successful candidate will also contribute to clinical trials, including randomized controlled trials (RCTs). The 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. Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies.

Your role within a pioneering company in full expansion:

Key Responsibilities

• Participate in the conception and design of Real-World Evidence studies, providing expert statistical support including study design, sample size determination, definition of study objectives and evaluation criteria, 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 project team and clinicians to interpret results, develop key messages, and contribute to scientific publications
• Work with clinicians and medical writers to communicate findings to clinical and regulatory partners, prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / …) and prepare summaries of results for regulatory documents
• Contribute to the RWE strategy for the submission dossier to FDA and EMA.
• 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.
• Follow all industry standards, including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF).

We offer an attractive remuneration/benefits package:

• Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, CE...

Qualifications / Experience

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 Real World Evidence studies from the outset.

• Advanced statistical analysis skills
• Proficiency in SAS software
• Strong understanding of real-world evidence studies design and methodology
• Familiarity with the specific methodologies and regulations associated with Real-World evidence studies.
• Comprehensive understanding of both primary data collection and secondary data re-utilization in studies.
• Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENcEPP)
• 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 interventional studies
• Knowledge of CDISC standards

Terms of Employment

Full-time position. Work location: full remotely or hybrid with 2 days per week from home.

Diversity and Inclusion

La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre. Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir l’égalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction d’origine, de sexe, d’âge, de situation de handicap, d’orientation sexuelle, d’identité de genre, de croyances ou de toute autre caractéristique protégée par la loi.

Les Laboratoires Pierre Fabre sont la 2ème entreprise dermo-cosmétique au monde et l’un des principaux laboratoires pharmaceutiques européens. Notre portefeuille Dermo-Cosmétique & Personal Care est composée de marques internationales dont Eau Thermale Avène, Ducray, Klorane, A-Derma, René Furterer, Même Cosmetics, Darrow et Elgydium. Notre activité Medical Care couvre 5 domaines thérapeutiques principaux : l’oncologie, la dermatologie, les maladies rares, les maladies chroniques et la santé familiale. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du « We Care Movement », un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensembles, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur.