Lead Statistical Programmer M/F

Pierre Fabre Laboratories; Boulogne-Billancourt; Hybride; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit sharing

Shareholding with matching

Health and provident insurance

RTT and holidays

Résumé du poste

Pierre Fabre Laboratories in Boulogne-Billancourt (92) or Toulouse (31) seeks a Lead Programmer for the Biometry Department. You will lead programming support for RCTs and Real World Evidence studies, ensuring regulatory-compliant data analysis, reporting, and visualization.

The role requires a strong track record in pharmaceutical programming, CDISC SDTM/ADaM, and collaboration with statisticians and data managers. Teleworking up to 2 days/week is possible under company policy.

Qualifications

• Minimum of 6 years of experience in the pharmaceutical industry or a CRO, with hands-on experience in RCTs and RWE studies.
• Proficiency in SAS and R programming languages and CDISC SDTM/ADaM with Define/ADRg documentation.
• Strong knowledge of ICH/EMA/FDA guidelines and ability to document programming work.
• Excellent written and verbal English communication; able to collaborate across functions.

Responsabilités

• 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 per regulatory standards.
• Collaborate with statisticians, data managers, and other stakeholders to ensure accurate data processing and analysis.
• Assist in selection and evaluation of subcontractors, defining requirements and evaluating proposals.
• Contribute to regulatory documents and scientific publications with programming expertise.
• Ensure biometry documentation is included in the eTMF and adhere to industry standards.

Connaissances

SAS

R programming

CDISC (SDTM & ADaM)

Regulatory guidelines (ICH/EMA/FDA)

English communication

Formation

Master's degree in Statistics or related field

Description du poste

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.