Lead Statistician Clinical Trials - CDI- M/F

Responsibilities

• 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).
• This position is compatible with teleworking up to 2 days a week according to company rules.
• 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, very attractive CE...
• Who you are ?
• Your skills at the service of innovative projects:
• 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, Ind

Benefits

Additional Information

Who we are ? We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the "We Care Movement". Your 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 based in Toulouse (31, Oncopole) or Boulogne (92) . 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. Your role within a pioneering company in full expansion:

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