Lead Statistician - Clinical Trials

Lead Statistician - Clinical Trials

Pierre Fabre

Haute-Garonne or Hauts-de-Seine, France

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.

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