Senior Late-Phase Statistician – Oncology, Regulatory Leader

Pierre Fabre Laboratories

Boulogne-Billancourt

Sur place

EUR 90 000 - 130 000

Plein temps

Il y a 25 heures
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Avantages offerts par ce poste

Incentives
Profit-sharing
Pierre Fabre shareholding with match
Health and provident insurance
16 RTT plus 25 personal holidays
Public transport participation

Résumé du poste

Pierre Fabre Laboratories is seeking a Senior Statistician to provide statistical leadership for late-stage clinical programs, mainly phase IIb/III randomized controlled trials and regulatory submissions.

You will design trials, define endpoints, manage missing data, and lead analyses using SAS and/or R, collaborating across Data Management, Programming, and Statistics to ensure robust evidence for regulatory decisions.

Qualifications

  • 6+ years in pharma/CRO with clinical trial development experience.
  • Experience in design, analysis and reporting of phase IIb/III RCTs.
  • Experience contributing to regulatory submissions or integrated efficacy/safety analyses is highly desirable.
  • Oncology trial experience preferred.

Responsabilités

  • Participate in design of phase IIb/III RCTs with statistical support.
  • Lead statistical definition of endpoints, populations, and multiplicity adjustments.
  • Oversee interim analyses and independent data monitoring committees when applicable.
  • Act as primary statistical contact for projects and liaise with regulatory partners.

Connaissances

Advanced statistical analysis
English communication
Regulatory coordination

Formation

Master's degree in Statistics
PhD in related field

Outils

SAS
R
CDISC standards

Description du poste

Pierre Fabre Laboratories is seeking a Senior Statistician to provide statistical leadership for late-stage clinical programs, mainly phase IIb/III randomized controlled trials and regulatory submissions.

You will design trials, define endpoints, manage missing data, and lead analyses using SAS and/or R, collaborating across Data Management, Programming, and Statistics to ensure robust evidence for regulatory decisions.

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