Senior Early Phase Statistician Clinical Development Hybrid

Pierre Fabre Pharmaceuticals, Inc.

Boulogne, Toulouse

Hybrid

EUR 90,000 - 120,000

Full time

3 days ago
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Benefits offered by this job

Profit-sharing
Shareholding with matchingContribution
Health and provident insurance
16 RTT days + 25 personal holidays

Job summary

Pierre Fabre Laboratories in France seeks a Senior Early Phase Statistician – Clinical Development to lead statistical input for first-in-human and dose-escalation studies. You’ll design analyses, support adaptive designs, and collaborate with cross-functional teams across Biometry, Pharmacology, and Regulatory affairs.

The role requires 6+ years in pharma/CRO, expertise in SAS or R, and strong knowledge of ICH/EMA/FDA guidelines; oncology experience is highly desirable.

Qualifications

  • Advanced degree in Statistics (Master's/PhD) or related field with at least 6 years in pharma/CRO.
  • Experience in early phase clinical trial development (first-in-human, dose-escalation).
  • Proficiency in SAS or R and strong knowledge of ICH/EMA/FDA guidelines.
  • Oncology experience is highly desirable.

Responsibilities

  • Lead design, execution and interpretation of early phase trials from FIH to proof-of-concept.
  • Provide expert statistical input on endpoints, estimands, analysis populations and sample size.
  • Develop and implement adaptive, model-based or Bayesian approaches when appropriate.
  • Collaborate across Biometry, Pharmacology, Translational Medicine and Regulatory teams.
  • Draft statistical sections for protocols and regulatory submissions; ensure timely deliverables.

Skills

Statistical leadership
Clinical trial design
Bayesian methods
Adaptive designs
Communication
Team collaboration

Education

Master's degree in Statistics

Tools

SAS
R

Job description

Pierre Fabre Laboratories in France seeks a Senior Early Phase Statistician – Clinical Development to lead statistical input for first-in-human and dose-escalation studies. You’ll design analyses, support adaptive designs, and collaborate with cross-functional teams across Biometry, Pharmacology, and Regulatory affairs.

The role requires 6+ years in pharma/CRO, expertise in SAS or R, and strong knowledge of ICH/EMA/FDA guidelines; oncology experience is highly desirable.

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