SDTM Programming

- Develop and validate SDTM domains for assigned studies.
- Generate SDTM validation reports and Pinnacle 21 compliance outputs.
- Prepare SDTM Reviewer's Guide and related support documents.

ADaM Programming

- Create analysis-ready datasets and implement dataset specifications.
- Develop ADaM validation programs and traceability documentation.
- Produce statistical tables, patient listings, safety figures, CSR outputs, and interim analysis deliverables.

Programming Quality

- Maintain programming review checklists and validation reports.
- Generate quality metrics reports and standard macro documentation.

Data Management & Reconciliation

- Prepare data review listings, missing data reports, and protocol deviation listings.
- Support query management metrics, SAE reconciliation, PK sample reconciliation, and external lab reconciliation.
- Handle eCOA/Paper COA reconciliation reports.

SAS Viya Expertise

- Develop CAS-enabled clinical programs.




- Implement automated reporting workflows.
- Conduct Viya migration testing and performance optimization.

Regulatory Submission Support

- Prepare SDTM and ADaM submission packages.
- Support Define.xml creation and complete CRT package assembly.

Qualifications

- 10+ years of clinical SAS programming experience.
- Solid expertise in SDTM and ADaM standards.
- Hands-on experience with SAS.
- Ability to work independently and lead programming deliverables.
- Experience across Phase 1 PK studies and Phases 2-4 in various therapeutic areas

Desired Skills

- Excellent problem-solving and analytical skills.
- Strong communication and documentation abilities.
- Ability to ensure compliance with industry standards.

Skills: Sdtm, ADAM, Sas

Experience: 0.00-0.00 Years

📌 Lead - SAS Programmer (Hyderabad)
🏢 Monster - xshruthix
📍 Hyderabad