Lead Statistical Programmer- CDI -M/F

Lead Statistical Programmer – Biometry Department

Position: Lead Statistical ProgrammerLocation: Toulouse (31), Langlade, Oncopole or Boulogne (92) – Teleworking possible up to 2 days per week

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 evaluating proposals.
• Support the preparation of regulatory documents and scientific publications by providing programming expertise.
• Follow industry standards, ensuring all biometry‑related documentation is included in the electronic Trial Master File (eTMF).

Qualifications

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

Optional Skills

• Experience with other statistical programming languages (e.g., Python, SQL).
• Knowledge of Real‑World Evidence (RWE) studies.
• Experience in EMA, FDA or PMDA submissions.
• Experience in oncology clinical trials.

Benefits

We offer an attractive remuneration and benefits package, including incentives, profit‑sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 personal holidays, and public transport participation.

EEO Statement

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.