Lead Statistician – Real World Evidence -CDI- M/F

Lead Statistician – Real World Evidence (RWE)

Pierre Fabre Laboratories is hiring an experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department in Toulouse (Oncopôle) or Boulogne, with the option to work remotely.

Key Responsibilities

• Participate in the conception and design of Real-World Evidence studies, including study design, sample size determination, definition of objectives and evaluation criteria, and development of statistical analysis plans.
• Act as the primary point of contact for all statistical aspects of assigned projects, attending meetings and providing statistical guidance.
• Contribute to the selection and evaluation of subcontractors, establishing requirements and evaluating proposals.
• Draft and validate key study documents (synopses, protocols, CRFs, data review plans, statistical analysis plans, statistical results, study reports) ensuring timely deliverables.
• Program and/or validate statistical analyses using SAS software.
• Collaborate with clinicians to interpret results, develop key messages, and contribute to scientific publications.
• Prepare responses to questions from regulatory agencies (EMA, FDA, PMDA, etc.) and summaries of results for regulatory documents.
• Contribute to the RWE strategy for submission dossiers to FDA and EMA.
• Oversee review of statistical documents within the team and supervise CRO activities, ensuring adherence to cost, timeline, and data quality requirements.
• Ensure compliance with industry standards and inclusion of statistical documentation in the electronic Trial Master File (eTMF).

Qualifications & Experience

• Advanced degree in Statistics (Master’s, ENSAI, ISUP, PhD) or a related field.
• Minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO), with significant involvement in Real-World Evidence studies from the outset.
• Advanced statistical analysis skills and proficiency in SAS.
• Strong understanding of RWE study design, methodology, and related regulations.
• Comprehensive knowledge of primary data collection and secondary data re-utilization.
• Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENcEPP).
• Excellent written and verbal communication skills in English.
• Strong ability to manage multiple studies simultaneously and maintain organization.
• Creativity, proactivity, rigor, autonomy, and a collaborative spirit.

Optional Skills

• Experience with interventional studies.
• Knowledge of CDISC standards.

Terms of Employment

Full-time position. Work location: fully remote or hybrid with two days per week from home.

Benefits

• Incentives and profit-sharing.
• Pierre Fabre shareholding with matching contribution.
• Health and provident insurance.
• 16 days of holidays (RTT) plus 25 days of personal holidays.
• Public transport participation.
• Other benefits as per company policy.

Equal Employment Opportunity Statement

We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or otherwise participating in the application process.