Lead Statistical Programmer M/F

We are currently seeking a highly skilled and experienced Lead Programmer to join our Biometry Department, part of the Data Science & Biometry Department in Boulogne (92) or in Toulouse (31).

This position requires a strong expertise in the application of programming within the context of randomized controlled trials (RCTs).

The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in Randomized Controlled Trials is a must, the successful candidate will also contribute to Real World Evidence (RWE) studies.

Your role within a pioneering company in full expansion:

Key Responsibilities:

• Participate in the design and execution of RCTs and 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.
• Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise.
• Follow all industry standards, including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF).

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package:

• Incentives
• profit-sharing
• Pierre Fabre shareholding with matching contribution
• health and provident insurance
• 16 days of holidays (RTT) in addition to 25 days of personal holidays
• public transport participation...

Your skills at the service of innovative Projects:

• 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 Contract Research Organization (CRO), with hands-on experience in RCTs and RWE studies.
• Programming in CDISC (SDTM & ADaM) and writing associated documentation (Define, ADRG...).

Mandatory Skills:

• Proficiency in SAS and R programming languagesExtensive experience in Randomized Controlled Trials (RCTs).
• Strong knowledge in CDISC (SDTM & ADaM) and associated documents (Define, ADRG, ...).
• Strong knowledge 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.
• Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
• 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.

The hiring manager is Romain Raymond, Programming & Biometry Platform Manager.

The Head of the Biometry Department is Guillaume Desachy.

We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.