Job Description

Job Overview

We are looking for an experienced Clinical SAS Programmer / SAS BI Engineer with strong expertise in clinical trial programming, CDISC standards, and regulatory submission deliverables. The ideal candidate should have hands-on experience in SDTM, ADaM, TFLs, and SDRG.

Key Responsibilities

Develop and maintain SAS programs for SDTM, ADaM, and TFLs.
Develop, validate, and review clinical trial datasets and programming outputs.
Generate Tables, Figures, and Listings (TFLs).
Prepare and maintain SDRG (Study Data Reviewer's Guide) documentation.
Ensure programming deliverables comply with CDISC standards and regulatory requirements.
Create submission-ready datasets and supporting documentation.
Review SAPs, Data Management Plans, and study-related documents.
Perform upstream clinical data review involving eDC and SDTM datasets.
Create and maintain Define.xml and metadata documentation.
Collaborate with cross-functional teams to deliver clinical programming requirements.
Support regulatory submission activities.
Identify opportunities for process improvement and programming automation.
Independently manage programming assignments and deliverables within timelines.

Mandatory Skills

8+ years of Clinical SAS Programming experience in Pharma, Biotechnology, or CRO environments.
Strong hands-on experience with:
SDTM
ADaM
TFLs – Tables, Figures & Listings
SDRG – Study Data Reviewer's Guide
Strong understanding of CDISC standards.
Clinical trial data and analysis dataset experience.
Experience with Define.xml and submission-ready deliverables.
Knowledge of regulatory submission requirements.
Experience with Pinnacle 21 and XML.
Strong SAS programming skills.