SDTM Programmer

ACURA SOLUTIONS LTD; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Shine.com is sourcing an experienced Senior SDTM Programmer for Bengaluru. The role requires at least 6+ years in clinical data programming, with strong SAS skills and knowledge of CDISC SDTM standards. You will annotate CRFs, develop and validate SDTM domains, and prepare regulatory submission deliverables.

The candidate should be proficient with Pinnacle 21, define.xml, and SDRG, and have exposure to SQL and Python. This is a full-time, on-site position in Bengaluru, India.

Qualifications

• Minimum 6 years of hands-on SDTM programming experience.
• Strong knowledge of CDISC standards, SDTM and SDTM IG.
• Experience in CRF annotation and SDTM domain development, validation and review.
• Proficiency in SAS programming.
• Familiarity with Pinnacle 21, define.xml, and SDRG.
• Knowledge of SQL and Python is 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 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

SAS programming

CDISC standards

SDTM programming

CRF annotation

SDTM domain development

Tools

Pinnacle 21

define.xml

SDRG

SQL

Python

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.

The ideal candidate should have strong SAS programming skills and hands‑on experience with clinical study submission deliverables, including Pinnacle 21 (P21), define.xml, and the Study Data Reviewer's Guide (SDRG).

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.

This job is provided by Shine.com