Lead Statistician – Clinical Trials M/F/D

Job title:

Lead Statistician – Clinical Trials M/F/D

Company

Pierre Fabre

Job description

Who we are ?Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.Pierre Fabre is recognized as one of the “World’s Best Employers 2021” by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.Your missionThe 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).

Who you are ?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 ProcessInterested 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.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.We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Expected salary

Location

Langlade, Gard – Toulouse

Job date

Wed, 06 Nov 2024 08:01:36 GMT

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