Lead Statistical Programmer M/F

Pierre Fabre Laboratories; Toulouse; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Pierre Fabre Laboratories, Boulogne (92) or Toulouse (31), is seeking a highly skilled Lead Programmer for the Biometry Department to support randomized controlled trials and Real World Evidence studies.

The role requires expertise in SAS and R, CDISC SDTM/ADaM, and strong collaboration with statisticians and data managers in a matrix environment, with exposure to regulatory standards (ICH, EMA, FDA).

Qualifications

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

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 (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).

Skills

SAS

R

CDISC SDTM/ADaM

Regulatory guidelines

English fluency

Communication

Team collaboration

Multi-study management

Education

Master's in Statistics

PhD in Statistics

Tools

CDISC Define

SAS/Studio

SDTM/ADaM definitions

Job description

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.