Senior SDTM/ADaM Programmer for Regulatory Submissions

DBV Technologies; New Jersey; On-site; USD 150,000 - 185,000; Full time

Job summary

DBV Technologies is seeking a senior statistical programmer to provide support for clinical studies, combining expertise in CDISC SDTM/ADaM with applied biostatistics. You will produce, validate, and review CDISC deliverables and support analyses under regulatory standards.

The role involves collaboration with biostatisticians, writing SAPs, and ensuring quality control with Pinnacle 21. A MSc/PhD and 8+ years in clinical trial programming are expected.

Qualifications

• Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or related field (e.g., ENSAI or equivalent).
• 8+ years of experience in statistical programming for clinical trials with CDISC SDTM/ADaM.
• Experience with regulatory submissions and CRO management is highly desirable.

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.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Statistical analysis

English fluency

Education

MSc or PhD in Biostatistics/Statistics/Mathematics

Tools

SAS Studio

SAS Viya

Pinnacle 21

Job description

DBV Technologies is seeking a senior statistical programmer to provide support for clinical studies, combining expertise in CDISC SDTM/ADaM with applied biostatistics. You will produce, validate, and review CDISC deliverables and support analyses under regulatory standards.

The role involves collaboration with biostatisticians, writing SAPs, and ensuring quality control with Pinnacle 21. A MSc/PhD and 8+ years in clinical trial programming are expected.