Role & responsibilities
Provide advanced statistical programming support for complex clinical research projects.
Develop, validate, and maintain clinical trial datasets and statistical outputs using SAS.
Apply advanced Base SAS, SAS Macros, and PROC SQL programming techniques.
Develop and support SDTM and ADaM datasets in accordance with CDISC standards.
Program and validate Tables, Listings, and Figures (TLFs/TLGs) based on study specifications and statistical analysis plans.
Translate protocols, SAPs, programming specifications, and mock shells into accurate programming deliverables.
Perform data manipulation, derivations, QC, validation, troubleshooting, and review of clinical trial datasets and outputs.
Prepare programming documentation, specifications, annotations, and related technical documentation.
Ensure programming deliverables meet applicable GCP, FDA, EMA, ICH, and other regulatory requirements.
Develop productive, well-documented, and reproducible programming code.
Collaborate with statisticians, biostatisticians, clinical data management, and other cross-functional teams.
Manage multiple study deliverables and priorities while maintaining quality and timelines.




Contribute to standardization and continuous improvement of statistical programming processes.

Preferred candidate profile
10+ years of relevant statistical programming experience, with 1012 years preferred.
Candidates with 13–14 years of experience may also be considered if the technical fit is solid.
Strong hands-on experience as a Statistical Programmer / Senior Statistical Programmer / Principal Statistical Programmer.
Strong clinical statistical programming experience within a pharmaceutical, CRO, biotechnology, or clinical research environment.
Strong proficiency in SAS, including Base SAS, SAS Macros, and PROC SQL.
Strong hands-on experience with SDTM, ADaM, TLF/TLG, and CDISC standards.
Positive understanding of clinical trial data flow and programming requirements.
Experience working with protocols, SAPs, programming specifications, mock shells, and clinical trial datasets.
Experience with programming QC, validation, and regulatory-compliant deliverables.
Knowledge of GCP and FDA/EMA/ICH regulatory requirements.
R or Python experience is an added advantage but not mandatory.
Additional exposure to Define.xml, CRF annotation, Pinnacle 21/OpenCDISC, and regulatory submissions is desirable.

📌 Senior Statistical Programmer Bengaluru
🏢 EMMES
📍 Bengaluru