Senior Early-Phase Statistician - Hybrid (Remote/Onsite)

PIERRE FABRE MEDICAMENT; Pechbusque; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Teleworking up to 2 days/week

Health and provident insurance

25 days holidays + RTT

Job summary

Pierre Fabre Laboratories in France seeks a Senior Early Phase Statistician – Clinical Development to lead statistical activities for early trials from first-in-human to proof-of-concept in Boulogne or Toulouse. You will design, analyze, and interpret data, collaborating with Clinical Development, Pharmacology, and Translational Medicine.

You will contribute with advanced design methods, regulatory input, and CRO coordination, ensuring high-quality eTMF documentation and proactive

Qualifications

• Advanced degree in Statistics (Master's, ENSAI, ISUP, or PhD) or related field.
• A minimum of 6 years of experience in pharma or CRO with clinical trial development.
• Experience in early phase trials including FIH, dose-escalation, dose-expansion, or PoC.
• Advanced statistical analysis skills.
• Proficiency in SAS or R.
• Strong understanding of trial design and methodology.
• Knowledge of Bayesian/adaptive methods and small-population approaches.
• Experience in quantitative decision-making for early phase.
• Ability to interpret complex, evolving clinical data.
• Strong knowledge of ICH/EMA/FDA guidelines and English communication.
• Experience in oncology trials.
• Optional: Biomarker data familiarity; RWE studies.

Responsibilities

• Design early phase trials (FIH, dose-escalation, expansion, PoC).
• Provide input on objectives, estimands, endpoints, and analysis populations.
• Contribute to dose-escalation and optimization using Bayesian/adaptive methods.
• Integrate safety, PK/PD data with clinicians for decisions.
• Define quantitative criteria for dose selection and Go/No-Go.
• Be primary statistical contact for projects and attend meetings.
• Draft/validate protocols, SAPs, CRFs, and study reports.
• Program analyses in SAS and/or R.
• Prepare regulatory responses and summaries.
• Evaluate CROs and manage outsourced stats activities.
• Ensure eTMF documentation meets standards.

Skills

Advanced statistics

Early-phase trials

SAS or R

English skills

Oncology trials

Regulatory knowledge

Clinical data analysis

Trial design

Education

Master's in Statistics

PhD in Statistics

Tools

SAS

R

Job description

Pierre Fabre Laboratories in France seeks a Senior Early Phase Statistician – Clinical Development to lead statistical activities for early trials from first-in-human to proof-of-concept in Boulogne or Toulouse. You will design, analyze, and interpret data, collaborating with Clinical Development, Pharmacology, and Translational Medicine.

You will contribute with advanced design methods, regulatory input, and CRO coordination, ensuring high-quality eTMF documentation and proactive