Clinical SAS Programmer

Tata Consultancy Services; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Tata Consultancy Services in Hyderabad, Telangana, is seeking a Senior Clinical SAS Programmer to lead CDISC-compliant data programming for late-phase studies.

You will develop and validate SDTM/ADaM datasets, create and validate TLFs, and support efficacy and safety analyses with independent SAS reviews. Define.xml validation, Pinnacle 21 knowledge, and end-to-end trial experience are highly regarded as you contribute to regulatory submissions.

Qualifications

• Experience in clinical SAS programming and data derivation.
• Proficient with CDISC SDTM/ADaM standards.
• Hands-on ADaM programming and TLF development.
• Define.xml validation and Pinnacle 21 experience.
• End-to-end clinical trial programming across phases.

Responsibilities

• Develop and validate SDTM and ADaM datasets.
• Create and validate TLFs for clinical studies.
• Support efficacy and safety analyses.
• Perform independent SAS programming and validation.
• Ensure CDISC and regulatory compliance.

Skills

Clinical SAS Programming

CDISC Standards (SDTM, ADaM)

ADaM Programming

TLF Development & Validation

Safety and Efficacy Programming

Define.xml and Pinnacle 21

End-to-End Clinical Trial Experience

Job description

Clinical SAS Programmer / Senior Clinical SAS Programmer

Experience: 5+ Years

Mandatory Skills:

• Clinical SAS Programming
• CDISC Standards (SDTM, ADaM)
• Strong hands-on ADaM Programming
• TLF Development & Validation
• Safety and Efficacy Programming
• Define.xml and Pinnacle 21
• End-to-End Clinical Trial Experience (Phase II/III)

Preferred Skills:

• Oncology, Neurology, or Immunology studies
• Regulatory Submission Support
• Reviewer/Lead experience
• Strong knowledge of derivations, imputations, and analysis datasets

Key Responsibilities:

• Develop and validate SDTM and ADaM datasets.
• Create and validate TLFs for clinical studies.
• Support efficacy and safety analyses.
• Perform independent SAS programming and validation.
• Ensure compliance with CDISC standards and regulatory requirements.