Senior Early-Phase Statistician — Hybrid (Remote 2d/wk)

Laboratoires Pierre Fabre

Boulogne-Billancourt

Hybrid

EUR 90,000 - 130,000

Full time

33 hours ago
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Benefits offered by this job

Incentives
Profit-sharing
Shareholding with matching
Health insurance
Provident insurance
16 RTT days + 25 personal days
Public transport participation

Job summary

Laboratoires Pierre Fabre in Boulogne-Billancourt seeks a Senior Early Phase Statistician to provide statistical leadership for early clinical development programs, from first-in-human studies through proof-of-concept.

You will design and analyze early phase trials, advise on estimands and decision criteria, apply model-based or adaptive methods, and collaborate with clinical, pharmacology and writing teams to support regulatory submissions.

Qualifications

  • Minimum 6 years’ experience in pharma/ CRO on early phase clinical development.
  • Experience with first-in-human, dose-escalation, dose-expansion, or proof-of-concept studies
  • Strong understanding of trial design, estimands and adaptive methods
  • Ability to generate regulatory-ready statistical documents and outputs
  • Excellent written and verbal English communication skills
  • Oncology trial experience is a plus

Responsibilities

  • Conceive and design early phase clinical trials (FIH, dose-escalation, dose-expansion, proof-of-concept).
  • Provide statistical input on objectives, endpoints, estimands, analysis populations and sample size.
  • Lead model-based, model-assisted, Bayesian or adaptive approaches where appropriate.
  • Collaborate with clinicians to integrate safety, PK/PD, biomarkers, and preliminary efficacy data.
  • Define quantitative decision criteria for dose selection and Go/No-Go decisions.
  • Draft or validate key study documents (synopses, protocols, CRFs, SAPs, reports).
  • Conduct analyses with SAS and/or R; support regulatory responses and scientific publications.

Skills

Advanced statistical analysis
English communication
Cross-functional collaboration

Education

Master's Degree in Statistics
PhD (related field)

Tools

SAS
R

Job description

Laboratoires Pierre Fabre in Boulogne-Billancourt seeks a Senior Early Phase Statistician to provide statistical leadership for early clinical development programs, from first-in-human studies through proof-of-concept.

You will design and analyze early phase trials, advise on estimands and decision criteria, apply model-based or adaptive methods, and collaborate with clinical, pharmacology and writing teams to support regulatory submissions.

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