SDTM Programmer

ACURA SOLUTIONS LTD; Chennai; On-site; INR 1,400,000 - 2,400,000; Full time

Job summary

ACURA SOLUTIONS LTD is seeking an experienced Senior SDTM Programmer with at least 6 years of hands-on SDTM programming in the clinical data domain. The role involves CRF annotation, SDTM domain development, validation, and ensuring compliance with CDISC standards for regulatory submissions.

Responsibilities include developing and validating SDTM datasets, preparing define.xml and Pinnacle 21 outputs, data quality checks, and collaboration with data management and statistics teams to ensure

Qualifications

• Minimum 6 years of relevant hands-on SDTM programming.
• Strong knowledge of CDISC standards, particularly SDTM and SDTM IG.
• Experience in CRF annotation and SDTM domain development, validation, and review.
• Working knowledge of Pinnacle 21 (P21), define.xml, and SDRG.
• Strong SAS programming skills.
• Knowledge of regulatory submission requirements.
• Working knowledge of SQL and Python will be an added advantage.

Responsibilities

• Perform CRF annotation in accordance with CDISC standards and study requirements.
• Develop, validate, and review SDTM datasets and domains.
• Ensure compliance with the SDTM Implementation Guide (SDTM IG) and applicable regulatory submission guidelines.
• Prepare and review submission deliverables, including define.xml, Pinnacle 21 validation outputs, and SDRG.
• Perform data validation, identify discrepancies, and resolve data quality issues.
• Apply advanced SAS programming skills to develop and validate clinical study datasets.
• Collaborate with clinical data management, statistical programming, and cross-functional teams to maintain data integrity and submission quality.

Skills

SDTM programming

SAS programming

CDISC standards

Tools

Pinnacle 21 (P21)

define.xml

SDRG

Job description

Job Title

SDTM Programmer

Experience

6+ Years

Industry

Clinical Research / Pharmaceutical / Biotechnology

Employment Type

Full-time

Job Summary

We are looking for an experienced Senior SDTM Programmer with a minimum of 6 years of relevant experience in clinical data programming. The candidate will be responsible for CRF annotation, developing, validating, and reviewing SDTM domains, and ensuring compliance with CDISC standards and regulatory submission requirements.

Key Responsibilities

• Perform CRF annotation in accordance with CDISC standards and study requirements.
• Develop, validate, and review SDTM datasets and domains.
• Ensure compliance with the SDTM Implementation Guide (SDTM IG) and applicable regulatory submission guidelines.
• Prepare and review submission deliverables, including define.xml, Pinnacle 21 validation outputs, and SDRG.
• Perform data validation, identify discrepancies, and resolve data quality issues.
• Apply advanced SAS programming skills to develop and validate clinical study datasets.
• Collaborate with clinical data management, statistical programming, and cross-functional teams to maintain data integrity and submission quality.

Required Skills And Qualifications

• Minimum 6 years of relevant hands‑on experience in SDTM programming.
• Strong knowledge of CDISC standards, particularly SDTM and SDTM IG.
• Practical experience in CRF annotation and SDTM domain development, validation, and review.
• Working knowledge of Pinnacle 21 (P21), define.xml, and SDRG.
• Strong SAS programming skills.
• Knowledge of clinical trial data and regulatory submission requirements.
• Working knowledge of SQL and Python will be an added advantage.

Preferred Candidate Profile

Candidates with experience in clinical research organizations (CROs), pharmaceutical companies, or biotechnology organizations and hands‑on involvement in clinical study submissions are preferred.