Senior Statistical Programmer (CDISC SDTM/ADaM)

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

Job Description

Provide support for clinical studies through dual expertise in statistical programming compliant with CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes the production, validation, and review of CDISC deliverables, as well as the execution and support of statistical analyses.

Responsibilities

• Participate in the design of clinical studies in collaboration with biostatisticians.




• Contribute to the writing and review of Statistical Analysis Plans (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.

Profile

• Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or a related field (e.g., ENSAI or equivalent).




• Minimum of 6–8 years of experience in statistical programming for clinical trials, with strong expertise in CDISC standards (SDTM/ADaM).




• Experience with regulatory submissions and CRO management is highly desirable.

Technical Skills

• Proficiency in SAS (Base SAS, SAS Studio, SAS Viya).




• Strong expertise in CDISC SDTM and ADaM standards.




• Good knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements.




• Experience using Pinnacle 21.




• Solid understanding of clinical statistics.




• Fluent English (written and spoken).

Behavioral Competencies

Curiosity
Continue exploring new horizons. Constantly ask \"Why?\" and, more importantly, \"Why not?\"

Courage
Take smart risks and support one another in continuously improving. Push boundaries, turn challenges into opportunities, and take ownership of our decisions, opinions, and actions.

Collaboration
Learn from one another. Grow and develop as a multicultural, international team working toward shared goals.

Credibility
Strive for excellence in everything we do. Transparency and expertise are the foundation of our relationships with patients, partners, and shareholders. Data and results are at the heart of our commitment.