Senior SAS Programmer: CDISC SDTM/ADaM for FDA Submissions

Venesco,-LLC-; Frederick (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Venesco, LLC seeks skilled SAS Programmers to develop validated statistical programs and CDISC-compliant datasets for clinical trials, safety reporting, and FDA submissions. You will collaborate with CDM and Biostatistics teams to ensure high-quality analyses.

Responsibilities include creating TLFs, SDTM/ADaM datasets, define.xml, validation plans, and supporting interim and final analyses through regulatory-ready programming.

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 programming

CDISC/SDTM/ADaM

FDA submissions

Validation practices

Education

Bachelor's degree in Statistics/CS/Math

Job description

Venesco, LLC seeks skilled SAS Programmers to develop validated statistical programs and CDISC-compliant datasets for clinical trials, safety reporting, and FDA submissions. You will collaborate with CDM and Biostatistics teams to ensure high-quality analyses.

Responsibilities include creating TLFs, SDTM/ADaM datasets, define.xml, validation plans, and supporting interim and final analyses through regulatory-ready programming.