Senior CDISC SDTM/ADaM Programmer - SAS & Submissions

DBV Technologies; Paris; Hybride; EUR 65 000 - 95 000; Plein temps

Résumé du poste

DBV Technologies in Paris seeks an experienced statistical programmer to provide support for clinical studies with CDISC SDTM/ADaM and applied biostatistics.

You will produce, validate, and review SDTM/ADaM deliverables, write SAPs, and support regulatory submissions using Pinnacle 21, with a focus on quality and compliance. The role requires strong SAS expertise and collaboration with clinical teams.

Qualifications

• Master’s degree or PhD in Biostatistics or related field.
• 6–8 years of statistical programming experience for clinical trials with CDISC SDTM/ADaM.
• Experience with regulatory submissions and CRO management is desirable.

Responsabilités

• Participate in the design of clinical studies with biostatisticians.
• Program, validate, and review SDTM/ADaM datasets and deliverables.
• Produce and validate Tables, Listings, and Figures (TLFs).
• Write and review SAPs; ensure regulatory submission readiness.
• Ensure regulatory compliance using Pinnacle 21.
• Collaborate with clinical and regulatory teams.

Connaissances

CDISC SDTM/ADaM expertise

Statistical programming for clinical

Regulatory submissions experience

English proficiency

Formation

Master's degree in Biostatistics

PhD in Biostatistics or related field

Outils

SAS (Base SAS, SAS Studio, SAS Viya)

Pinnacle 21

Description du poste

DBV Technologies in Paris seeks an experienced statistical programmer to provide support for clinical studies with CDISC SDTM/ADaM and applied biostatistics.

You will produce, validate, and review SDTM/ADaM deliverables, write SAPs, and support regulatory submissions using Pinnacle 21, with a focus on quality and compliance. The role requires strong SAS expertise and collaboration with clinical teams.