Job Description
- Review Protocol, CRFs, Annotated CRFs, Statistical Analysis Plan (SAP), and Mock Shells.
- Develop and validate SDTM domains and ADaM datasets for Safety and Efficacy studies.
- Develop and validate Tables, Listings & Figures (TLFs) using SAP and Mock Shells.
- Create and review P21 Validation Reports , Define.xml Packages , and Reviewer Guides (RGs) for CDISC standards.
- Work independently and collaborate effectively within cross-functional teams.
- Provide regular status updates to the Study Lead Programmer.
- Participate in study meetings and support as a Backup Lead.
- Identify, communicate, and manage study risks and issues.
- Maintain study documentation in accordance with SOPs and Work Instructions (WI).
- Contribute to Statistical Programming standards, quality improvements, and process optimization.
- Stay updated with CDISC standards, GCP, ICH guidelines, and therapeutic area requirements.




- Mentor and train junior Statistical Programmers.
- Perform end-to-end clinical programming activities across SDTM, ADaM, TLFs, and R Programming.

Skills Required

SDTM, ADaM, TLF Programming, Safety Programming, Efficacy Programming, Advanced SAS, R Programming, Define.xml, Reviewer Guide, CRF Annotation, CDISC Standards, Clinical Trials Phase IIV, Therapeutic Area Knowledge, GCP, ICH Guidelines, Study Documentation, Risk Management, Team Collaboration, Mentoring, Regulatory Compliance

Experience Required

5-15 years

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Principal Statistical Programmer (Bengaluru)
🏢 D2kss Software Services
📍 Bengaluru