Lead Biostatistics Programmer - RCT & RWE (SAS/R)

Pierre Fabre Laboratories; Toulouse; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

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).

Qualifikationen

• 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...).

Aufgaben

• 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).

Kenntnisse

SAS

R

CDISC SDTM/ADaM

Regulatory guidelines

English fluency

Communication

Team collaboration

Multi-study management

Ausbildung

Master's in Statistics

PhD in Statistics

Tools

CDISC Define

SAS/Studio

SDTM/ADaM definitions

Jobbeschreibung

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).