Hybrid Lead Statistical Programmer

at Pierre Fabre Group

• Job title: Lead Statistical Programmer
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Toulouse, France

About the role

• Lead Statistical Programmer with expertise in RCTs at Pierre Fabre, contributing to data analysis and regulatory documentation for the pharmaceutical sector.

Responsibilities

• Participate in the design and execution of Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies, ensuring high-quality programming support.
• Develop and validate programs for data analysis, reporting, and visualization in accordance with regulatory guidelines and standards (e.g., ICH, EMA, FDA, PMDA).
• Collaborate with statisticians, data managers, and other stakeholders to ensure accurate and efficient data processing and analysis.
• Assist in the selection and evaluation of subcontractors, establishing clear requirements and assessing proposals.
• Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise.
• Adhere to industry standards, including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF).

Requirements

• Advanced degree in Statistics (Master's degree, ENSAI, ISUP, or PhD) or a related field.
• Minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO), with hands-on experience in RCTs and RWE studies.
• Experience programming to CDISC standards (SDTM & ADaM) and writing associated documentation (e.g., Define, ADRG...).
• Proficiency in SAS and R programming languages.
• Extensive experience with Randomized Controlled Trials (RCTs).
• Strong knowledge of CDISC (SDTM & ADaM) and associated documents (Define, ADRG, ...).
• Solid understanding of international scientific and regulatory recommendations (e.g., ICH, EMA, FDA).
• Ability to collaborate effectively with statisticians, data managers, and other stakeholders.
• Excellent written and verbal communication skills in English.
• Strong communication and teamwork skills, with a rigorous and pragmatic approach.
• Creativity, proactivity, rigor, autonomy, and a collaborative spirit.
• Strong ability to manage multiple studies simultaneously and stay organized.

Benefits

• Incentives
• Profit-sharing
• Pierre Fabre share ownership plan with company matching contribution
• Health and provident insurance
• 16 days of RTT (time-off in lieu) in addition to 25 days of annual leave
• Public transport subsidy
• Very attractive employee benefits (works council)