We’re Hiring | Clinical SAS Programmer / SAS BI Engineer

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.

Good to Have

• 10+ years of Clinical/Statistical Programming experience.
• Experience supporting NDA, BLA, and MAA submissions.
• R programming experience.
• Knowledge of clinical endpoints and medical terminology.
• Linux/Unix exposure.
• Process automation and programming efficiency experience.
• Experience mentoring junior programmers or leading programming projects.
• Strong communication and stakeholder management skills.

Notice Period

Immediate Joiners to 45 Days can be considered.