Clinical Sas Programmer

Tata Consultancy Services; Ahmedabad District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Tata Consultancy Services invites an experienced Clinical SAS Programmer to join our clinical analytics team in India.

The role focuses on developing and validating CDISC SDTM/ADaM datasets, creating TLFs, and supporting safety and efficacy analyses across Phase II/III studies.

Ideal candidates will have hands-on ADaM programming and familiarity with Define.xml and Pinnacle 21 to ensure regulatory compliance.

Qualifications

• Must have experience in Clinical SAS programming with CDISC SDTM/ADaM.
• Hands-on ADaM programming and derivations.
• Experience with TLF development and validation.
• Familiarity with Define.xml and Pinnacle 21.
• End-to-end clinical trial experience (Phase II/III).

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.

Skills

Clinical SAS Programming

CDISC SDTM/ADaM

ADaM Programming

TLF Development/Validation

Safety & Efficacy Programming

Define.xml Pinnacle 21

End-to-End Trials (Phase II/III)

Tools

Define.xml

Pinnacle 21

Job description

Clinical SAS Programmer / Senior Clinical SAS Programmer

Experience: 2-6 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.