Description

You will develop and maintain SAS programs to generate SDTM, ADaM datasets, and TFLs. You will own the programming lifecycle from specification through validation.

Responsibilities

• Create programs to perform QC of SDTM, ADaM, and TFL outputs.
• Develop SDTM specifications based on CRFs and raw data, including CRF annotation per CDISC standards.
• Build ADaM specifications following Statistical Analysis Plans (SAP) and TFL shells.
• Generate Pinnacle 21 reports, update programs, and address conformance check comments.
• Review SAPs and TFL shells from a programming perspective and author SDTM/ADaM Reviewers Guides.

Required Skills

• 5+ years of experience in SAS programming.
• Expertise in creating SDTM datasets.
• Expertise in creating ADaM datasets.
• Experience generating TFLs for clinical publications, including tables, listings, and figures.
• Proficiency with TFL shells.
• Knowledge of CDISC SDTM standards for CRF annotation.
• Ability to interpret Statistical Analysis Plans (SAP).
• Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or equivalent experience.

Key Skills

Education

Any Graduate