Statistical Programmer

Tata Consultancy Services; Hyderabad; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Tata Consultancy Services in Hyderabad is seeking a Clinical SAS Programmer to develop and validate SDTM/Adam datasets and create TLFs for clinical studies across Phase II/III trials.

Join a team delivering safety and efficacy analyses with end-to-end clinical trial programming. Requires 2–6 years of hands-on SAS programming, CDISC standards (SDTM/Adam), and Define.xml/Pinnacle 21 expertise. On-site roles in Hyderabad/Ahmedabad.

Qualifications

• 2-6 years of clinical SAS programming experience.
• Strong knowledge of CDISC SDTM and Adam standards.
• Hands-on Adam programming and Define.xml/Pinnacle 21.
• Experience with safety and efficacy analyses in clinical trials.

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

CDISC SDTM

Adam

TLF Development

TLF Validation

Safety Analysis

Efficacy Analysis

Define.xml

Pinnacle 21

Phase II/III

End-to-End Trials

Tools

SAS

Job description

Job Title: Clinical SAS Programmer/ Statistical Programmer

Experience: 2-6 Years

Location: Hyderabad , Ahmedabad

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.