Senior CDISC SDTM/ADaM Programmer for Submissions

DBV Technologies; New Jersey; On-site; USD 130,000 - 190,000; Full time

Job summary

DBV Technologies is seeking a senior biostatistics professional to support clinical studies with dual expertise in statistical programming aligned to CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes producing, validating, and reviewing CDISC deliverables and executing statistical analyses.

The ideal candidate holds a MSc/PhD in Biostatistics or a related field with 6–8 years of CDISC programming experience, plus SAS proficiency and Pinnacle 21 knowledge for regulatory

Qualifications

• Master's degree or PhD in Biostatistics, Statistics, Mathematics, 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.

Responsibilities

• Participate in the design of clinical studies with biostatisticians.
• Write and review Statistical Analysis Plans (SAPs).
• Program and validate SDTM and ADaM datasets.
• Produce and review SDTM/ADaM deliverables and TLFs.
• Ensure regulatory compliance using Pinnacle 21.
• Contribute to regulatory submission packages and Define.xml.
• Perform QC activities and collaborate with clinical/regulatory teams.

Skills

Statistical programming

CDISC SDTM/ADaM

Clinical statistics

Education

Master's degree in Biostatistics or related field

PhD or MSc in Biostatistics/Statistics/Mathematics

Tools

SAS (Base SAS, SAS Studio, SAS Viya)

Pinnacle 21

Job description

DBV Technologies is seeking a senior biostatistics professional to support clinical studies with dual expertise in statistical programming aligned to CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes producing, validating, and reviewing CDISC deliverables and executing statistical analyses.

The ideal candidate holds a MSc/PhD in Biostatistics or a related field with 6–8 years of CDISC programming experience, plus SAS proficiency and Pinnacle 21 knowledge for regulatory