Senior SAS Programmer: CDISC SDTM/ADaM for FDA Submissions

Venesco, LLC; Frederick (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

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

Duties include developing and validating SAS programs, generating TLFs, and producing SDTM/ADaM/SEND datasets. This role collaborates with CDM and Biostatistics teams and supports FDA submissions.

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.
• Must be eligible for clearance / US Citizenship required.

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 standards

FDA submissions

Validation practices and regulatory

Education

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

SAS Advanced Programmer Certification

Job description

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

Duties include developing and validating SAS programs, generating TLFs, and producing SDTM/ADaM/SEND datasets. This role collaborates with CDM and Biostatistics teams and supports FDA submissions.