Senior SAS Programmer — SDTM/ADaM for FDA Submissions

Venesco, LLC; Maryland; On-site; USD 110,000 - 160,000; Full time

Job summary

Venesco, LLC is seeking a skilled SAS Programmer to develop validated statistical programs and CDISC-compliant datasets to support clinical trials, statistical analyses, safety reporting, and FDA submissions.

The ideal candidate has a Bachelor's degree in a related field, at least 7 years of clinical SAS programming experience, and SAS Advanced Programmer Certification. You will produce TLFs, SDTM/ADaM datasets, define.xml, and submission-ready programs while maintaining documentation.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or related field.
• SAS Advanced Programmer Certification required.
• Minimum 7 years of clinical SAS programming experience.
• Extensive experience with CDISC, SDTM, and ADaM standards.
• Experience supporting FDA submissions.
• Strong knowledge of validation practices and regulatory requirements.

Responsibilities

• Develop and validate SAS programs.
• Produce Tables, Listings, and Figures (TLFs).
• Generate SDTM, ADaM, and SEND datasets.
• Develop define.xml files and reviewer guides.
• Create programming validation plans and reports.
• Develop randomization programs and statistical outputs.
• Support interim and final analyses.
• Assist with FDA submission packages.
• Collaborate with Clinical Data Management and Biostatistics teams.
• Maintain programming documentation and standards.

Skills

SAS Advanced Programmer Certification

CDISC SDTM ADaM expertise

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, or related field

Job description

Venesco, LLC is seeking a skilled SAS Programmer to develop validated statistical programs and CDISC-compliant datasets to support clinical trials, statistical analyses, safety reporting, and FDA submissions.

The ideal candidate has a Bachelor's degree in a related field, at least 7 years of clinical SAS programming experience, and SAS Advanced Programmer Certification. You will produce TLFs, SDTM/ADaM datasets, define.xml, and submission-ready programs while maintaining documentation.