Senior Statistical Programmer (CDISC SDTM/ADaM)

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

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.