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.
