Description

You will develop and maintain SAS programs to produce SDTM, ADaM datasets, and TFLs for clinical trials.

Responsibilities

• Create SAS programs for SDTM and ADaM datasets, including QC processes and TFL generation.
• Develop SDTM specifications from CRFs and raw data, and ADaM specifications based on SAP and TFL shells.
• Annotate Case Report Forms (CRF) following CDISC SDTM standards.
• Generate Pinnacle 21 reports, manage conformance checks, and validate Define files.
• Review SAPs and TFL shells from a programming perspective and prepare SDTM/ADaM Reviewers Guides.

Required Skills

• 3+ years of experience in SAS programming.
• Proficiency in creating SDTM datasets.
• Experience developing ADaM datasets.
• Ability to generate TFLs (Tables, Listings, and Figures).
• Knowledge of CDISC SDTM standards.
• Experience with Pinnacle 21 for conformance checking.
• Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or equivalent experience.

Key Skills

Education

Any Graduate