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 efficient, 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.
- Good 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