Senior Phase II/III Statistician — Regulatory Strategy

PIERRE FABRE MEDICAMENT; Pechbusque; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Incentives

Profit-sharing

Pierre Fabre shareholding with matched

Health and provident insurance

16 RTT holidays + 25 personal days

Job summary

Pierre Fabre Laboratories is seeking a Senior Statistician with 6+ years of experience to lead statistical aspects of late-stage clinical development, including phase IIb/III randomized trials and regulatory submissions.

The role requires strong expertise in estimands, missing data, multiplicity, and safety analyses, with SAS and/or R programming. On-site in Toulouse Langlade or Boulogne, with up to 2 days remote per week.

Qualifications

• Advanced statistical analysis skills.
• Proficiency in SAS or R.
• Experience with Phase IIb/III development and regulatory strategy.
• Experience supporting regulatory submissions to EMA/FDA/PMDA.

Responsibilities

• Lead statistical design and analysis for phase IIb/III trials and contribute to regulatory submissions.
• Oversee missing data, sensitivity analyses, and multiplicity control.
• Collaborate with clinicians and medical writers on regulatory documents.

Skills

Statistical analysis

SAS

R

Clinical trials

Regulatory submissions

ICH guidelines

English skills

Education

Master's or PhD in Statistics

Tools

SAS

R

Job description

Pierre Fabre Laboratories is seeking a Senior Statistician with 6+ years of experience to lead statistical aspects of late-stage clinical development, including phase IIb/III randomized trials and regulatory submissions.

The role requires strong expertise in estimands, missing data, multiplicity, and safety analyses, with SAS and/or R programming. On-site in Toulouse Langlade or Boulogne, with up to 2 days remote per week.