Lead Statistical Programmer (CDI) - M/F

About the role

Pierre Fabre Laboratories is looking for an experienced Lead Statistical Programmer to join its Biometry Department, part of the Data Science & Biometry Department, based in Toulouse or Boulogne. The role requires strong expertise in applying programming within randomized controlled trials (RCTs) and calls for agility in a matrix organisation where collaboration across Data Management, Programming and Statistics is essential. It also involves contributing to Real World Evidence (RWE) studies.

Key responsibilities

• Take part in the design and execution of RCTs and RWE studies, providing high-quality programming support.
• Develop and validate programmes for data analysis, reporting and visualisation in line with regulatory guidelines (ICH, EMA, FDA, PMDA).
• Work with statisticians, data managers and other stakeholders to ensure accurate and efficient data processing and analysis.
• Help select and evaluate subcontractors, setting clear requirements and assessing proposals.
• Support the preparation of regulatory documents and scientific publications.
• Ensure biometry documentation is included in the electronic Trial Master File (eTMF).

Required profile

• Advanced degree in Statistics (Master's, ENSAI, ISUP or PhD) or a related field.
• At least 6 years of experience in pharma or a CRO, with hands-on RCT and RWE experience.
• Extensive experience in RCTs and strong knowledge of international regulatory recommendations (ICH, EMA, FDA).
• Excellent written and spoken English and the ability to work with statisticians and data managers.

Required skills

• Programming in CDISC (SDTM and ADaM) and writing associated documentation (Define, ADRG).
• Proficiency in SAS and R.
• Optional: Python, SQL, RWE study experience, EMA/FDA/PMDA submission experience, oncology trial experience.

What we offer

• Remuneration and benefits package including incentives, profit-sharing and shareholding with matching contribution.
• Health and provident insurance, 16 days of RTT leave plus 25 days of personal leave, and public transport participation.
• Teleworking up to 2 days a week according to company rules.

Candidates apply by submitting a CV and a cover letter describing their experience and qualifications; the hiring manager is Romain Raymond.