Senior SDTM/ADaM Statistical Programmer (CDISC)

DBV Technologies; Châtillon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

DBV Technologies in France seeks an experienced Statistical Programmer to support clinical studies with CDISC SDTM/ADaM and applied biostatistics. You will produce, validate, and review CDISC deliverables and contribute to study design.

The role requires 6–8 years in statistical programming for clinical trials, strong CDISC expertise, and SAS/Pinnacle 21 skills, with collaboration across clinical and regulatory teams.

Qualifications

• Master's degree or PhD in Biostatistics or a related field.
• 6–8 years of statistical programming experience in clinical trials.
• Strong knowledge of CDISC SDTM/ADaM.

Responsabilités

• Participate in the design of clinical studies in collaboration with biostatisticians.
• Contribute to the writing and review of SAPs.
• Program and validate SDTM and ADaM datasets.
• Produce, validate, and review SDTM/ADaM deliverables (annotated CRFs, specifications, datasets).
• Ensure regulatory compliance using Pinnacle 21.
• Participate in and validate regulatory submission deliverables (Define.xml, submission packages).
• Perform Quality Control (QC) activities.
• Produce and validate Tables, Listings, and Figures (TLFs).
• Collaborate closely with clinical and regulatory teams.

Connaissances

Statistical programming

CDISC SDTM/ADaM

Regulatory submission support

Clinical statistics understanding

Collaborative cross-functional work

Formation

Master's degree or PhD in Biostatistics/Statistics/Mathematics

Outils

SAS

SAS Studio

SAS Viya

Pinnacle 21

Description du poste

DBV Technologies in France seeks an experienced Statistical Programmer to support clinical studies with CDISC SDTM/ADaM and applied biostatistics. You will produce, validate, and review CDISC deliverables and contribute to study design.

The role requires 6–8 years in statistical programming for clinical trials, strong CDISC expertise, and SAS/Pinnacle 21 skills, with collaboration across clinical and regulatory teams.