Senior Early-Phase Statistician, Clinical Development

PIERRE FABRE; Occitanie; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Pierre Fabre Laboratories seeks a Senior Early Phase Statistician to lead statistics in Clinical Development, guiding first-in-human and proof-of-concept trials from Boulogne or Toulouse. You will design studies, define estimands, and drive adaptive approaches with a matrix team across Clinical Development, Pharmacology, and Data Management.

Applicants should have an advanced statistics degree, 6+ years in pharma/CRO, and strong SAS/R expertise for regulatory-ready analyses and reporting.

Qualifications

• Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field.
• A minimum of 6 years of experience in the pharmaceutical industry or a CRO, with significant involvement in clinical trial development from the outset.
• Previous experience supporting early phase clinical trials, ideally including first-in-human, dose-escalation, dose-expansion, or proof-of-concept studies
• Advanced statistical analysis skills
• Proficiency in at least one of the following two statistical software: SAS or R
• Strong understanding of clinical trial design and methodology
• Knowledge of methodologies relevant to early clinical development, such as Bayesian methods, adaptive designs, dose-escalation methods

Responsabilités

• Participate in the conception and design of early phase clinical trials, including first-in-human, dose-escalation, dose-expansion, and proof-of-concept studies.
• Provide expert statistical input into objective definitions, endpoints, estimands, analysis populations, and sample size considerations.
• Contribute to dose-escalation and dose-optimization strategies, including model-based, model-assisted, Bayesian, or adaptive approaches.
• Collaborate with clinicians to integrate safety, PK/PD, biomarkers, and preliminary efficacy data.
• Support quantitative decision criteria for dose selection, cohort expansion, proof of mechanism, and Go/No-Go decisions.
• Act as the primary statistical contact for assigned projects and attend study meetings.
• Draft/validate key study documents and SAPs; ensure timely deliverables.
• Program/validate analyses using SAS and/or R.
• Assist with regulatory responses and summaries for agencies.
• Contribute to CRO selection and evaluation; ensure cost, timeline, and data quality.
• Oversee statistical documentation within the team and outsourced activities to CROs.
• Follow industry standards and ensure eTMF inclusion for statistics-related documents.

Connaissances

Statistics degree

Clinical trial experience

Early phase trials

Advanced statistics

SAS or R

Bayesian methods

Adaptive designs

Formation

Advanced degree in Statistics

Outils

SAS

R

Description du poste

Pierre Fabre Laboratories seeks a Senior Early Phase Statistician to lead statistics in Clinical Development, guiding first-in-human and proof-of-concept trials from Boulogne or Toulouse. You will design studies, define estimands, and drive adaptive approaches with a matrix team across Clinical Development, Pharmacology, and Data Management.

Applicants should have an advanced statistics degree, 6+ years in pharma/CRO, and strong SAS/R expertise for regulatory-ready analyses and reporting.