Lead Statistician Clinical Trials - CDI- M/F

Key Responsibilities

• Participate in conception and design of Randomized Controlled Trials, including study design, sample size determination, definition of objectives and estimates, writing statistical section of protocol and developing statistical analysis plan.
• Act as internal and external primary statistical point of contact, attending meetings and providing guidance.
• Contribute to selection and evaluation of subcontractors and establish clear requirements.
• Draft and validate study documents: synopses, protocols, CRFs, data review plans, statistical analysis plans, results, study reports, ensuring timely deliverables.
• Program and/or validate statistical analyses using SAS.
• Collaborate with clinicians to interpret results, develop key messages, and communicate findings to clinical and regulatory partners.
• Prepare responses to regulatory agencies (EMA, FDA, PMDA, etc.) and summaries for regulatory documents and scientific articles.
• Oversee review of statistical documents within the team and supervise CRO operations, ensuring adherence to cost, timeline, and data quality.
• Participate in submission dossier strategy to FDA and EMA.
• Coordinate production of safety and efficacy integrated pools and related analyses.
• Ensure all statistical documentation is included in the electronic Trial Master File (eTMF).

Qualifications

• Advanced degree in Statistics (Master’s, ENSAI, ISUP, PhD) or related field.
• Minimum of 6 years in pharmaceutical industry or CRO, with extensive clinical trial development experience.
• Strong experience in oncology clinical trials.
• Proficiency with SAS or R.
• Deep understanding of clinical trial design, methodology, and advanced concepts such as Bayesian, Adaptive Designs, Basket/Umbrella/Platform trials, Multiple‑Testing Adjustment, Small Populations, Individualized Treatment Effects.
• Knowledge of international guidelines (ICH, EMA, FDA, etc.).
• Excellent written and verbal communication in English.
• Strong collaboration skills, 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.
• Experience with machine learning techniques.
• Experience with biomarker data and its application in randomized controlled trial designs.

Benefits

• Incentives, profit sharing, and shareholding program with matching contribution.
• Health and provident insurance.
• 16 days of holidays (RTT) plus 25 personal holidays.
• Public transport participation and other benefits (details to be confirmed).
• Teleworking up to 2 days a week, per company rules.

Position Details

Location: Toulouse (31, Oncopole) or Boulogne (92). The role is compatible with up to 2 days of teleworking per week.

Equal Employment Opportunity Statement

At Pierre Fabre Laboratories, we are committed to equal employment opportunity and non‑discrimination. We do not discriminate on the basis of race, color, religion, creed, national origin, sex, sexual orientation, gender identity or expression, age, disability, veteran or military status, genetic information, or any other legally protected basis. Reasonable accommodations are available for applicants with disabilities.