Lead Statistician - Real World Evidence M/F

Lead Statistician – Real World Evidence M/F

Join to apply for the Lead Statistician – Real World Evidence M/F role at Pierre Fabre Laboratories .

Pierre Fabre Laboratories is hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department. The position is based in Toulouse (Oncopôle) or Boulogne and can be filled remotely.

This role requires strong expertise in the application of statistics within Real‑World Evidence studies. The successful candidate will be agile, adaptable, and able to work in a matrix‑organized environment where collaboration across Data Management, Programming, and Statistics is essential. While an excellent track record in RWE is a must, the candidate will also contribute to clinical trials, including randomized controlled trials (RCTs).

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, and writing the statistical section of the protocol and statistical analysis plan.
• Act as the primary point of contact internally and externally for all statistical aspects of assigned projects, 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 plans, statistical results, and study reports, ensuring timely deliverables.
• Program and/or validate statistical analyses using SAS software.
• Collaborate with the 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, including preparing responses to regulatory agency questions (EMA, FDA, PMDA, etc.) and summary 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 outsourced operational activities to CROs, ensuring adherence to cost, timeline, and data quality requirements.
• Follow all industry standards, ensuring that all statistical documentation is included in the electronic Trial Master File (eTMF).

Qualifications / Experience

• Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field.
• Minimum of 6 years’ experience in the pharmaceutical industry or a Contract Research Organization (CRO), with significant involvement in Real‑World Evidence studies from the outset.

Mandatory Skills

• 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 CDI SC Standards.

Terms of Employment

• Full‑time position.
• Work location: fully remote or hybrid with 2 days per week from home.

Application Process

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

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.