Lead programmer- m/f/d

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
We are currently seeking a highly skilled and experienced Lead Programmer to join our Biometry Department, part of the Data Science & Biometry Department.

This position requires a strong expertise in the application of programming within the context of 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 Worl Evidence (RWE) studies.

Key Responsibilities- Participate in the design and execution of RCTs and RWE studies, ensuring high-quality programming support.
- Develop and validate programs for data analysis, reporting, and visualization in accordance with regulatory guidelines and standards (e.g., ICH, EMA, FDA, PMDA).
- Collaborate with statisticians, data managers, and other stakeholders to ensure accurate and efficient data processing and analysis.
- Assist in the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals.
- Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise.
- Follow all industry standards, including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF).

Qui êtes-vous ?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 hands-on experience in RCTs and RWE studies.
- Programming in CDISC (SDTM & ADaM) and writing associated documentation (Define, ADRG...)

Mandatory Skills- Proficiency in SAS and R programming languages
- Extensive experience in Randomized Controlled Trials (RCTs)
- Strong knowledge in CDISC (SDTM & ADaM) and associated documents (Define, ADRG, ...)
- Strong knowledge of international scientific and regulatory recommendations (e.g., ICH, EMA, FDA)
- Ability to collaborate effectively with statisticians, data managers, and other stakeholders
- 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 other statistical programming languages (e.g., Python, SQL)
- Knowledge of Real-World Evidence (RWE) studies
- Experience in EMA, FDA or PMDA submissions
- Experience in oncology clinical trials

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

The hiring manager is Romain Raymond, Programming & Biometry Platform 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.

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.