Job Summary
We are hiring an experienced Statistical / Clinical SAS Programmer with strong expertise in clinical trial data analysis, CDISC standards (SDTM/ADaM) and regulatory submissions. The role involves end-to-end statistical programming support for Phase IIV clinical studies.
Key Responsibilities
- Develop and validate SDTM and ADaM datasets as per CDISC standards
- Generate Tables, Listings, and Figures (TLFs)
- Support regulatory submissions (FDA/EMA NDA, BLA, MAA)
- Perform clinical data analysis using SAS
- Ensure compliance with ICH-GCP and 21 CFR Part 11
- Work closely with statisticians, data management, and clinical teams
Required Skills
- SAS Programming (Base SAS, Macro, SQL)
- CDISC standards: SDTM, ADaM
- Clinical Trials (Phase IIV)
- Regulatory Reporting
- Strong understanding of clinical data structures
Preferred Skills
- Experience with R
- Knowledge of Pinnacle 21, Define.xml, XML
- Exposure to Linux environment
Experience
- 8+ years of statistical / clinical programming experience
- Pharma / CRO background preferred
Education
- Bachelor's or Master's in Statistics / Biostatistics / Mathematics / Computer Science / Life Sciences
Location
Bangalore, India
Workplace Profile- Remote
