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SDTM Programmer
Ref No.: 26-00262
Location: Bangalore, Karnataka
Start Date: 07/07/2026
Important Sourcing Guidelines:
  • Please focus on candidates with strong SDTM programming experience.
  • Even if additional preferred skills are not explicitly mentioned on the resume, candidates with solid SDTM expertise should be prioritized.
  • Please avoid submitting profiles of candidates with a history of frequent job changes. Specifically, candidates who have changed 4–5 jobs within the last 6 years should not be considered, as stability and long-term commitment are important for this role.

Kindly share relevant profiles at the earliest.

Key Responsibilities
  • Develop, validate, and maintain SAS programs for the creation, validation, and delivery of SDTM datasets in compliance with CDISC standards and study requirements.
  • Perform independent programming validation and quality control to ensure the accuracy, consistency, and integrity of SDTM datasets and related deliverables.
  • Provide statistical programming support to project teams, including the development of programming strategies, standards, specifications, and data conversion processes.
  • Review and interpret study protocols, CRFs, data management documents, and mapping specifications to support SDTM implementation.
  • Contribute to the preparation, review, and support of electronic submissions for regulatory agencies.
  • Review key planning documents, including Data Review Plans and other study specifications, to ensure alignment with project objectives and programming requirements.
  • Assess the impact of protocol amendments, CRF changes, and data updates on SDTM programming activities and timelines.
  • Collaborate with internal stakeholders and external vendors on CDISC standards, programming conventions, specifications, data transfers, and deliverables.
  • Ensure compliance with regulatory requirements, industry standards, company SOPs, and departmental best practices.
  • Identify and implement opportunities to improve efficiency, quality, standardization, and consistency across SDTM programming activities.
  • Independently lead and execute programming assignments with minimal supervision while providing guidance to junior programmers as needed.
  • Support process improvement initiatives and contribute to the development of reusable macros, standards, and programming utilities.
Skills, Knowledge, and Experience
Required Qualifications
  • Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.
  • 7–10 years of clinical/statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
  • Strong proficiency in SAS programming with extensive experience in clinical trial data processing and reporting.
  • Strong hands-on experience in CDISC SDTM implementation, mapping, validation, and submission readiness.
  • Thorough understanding of clinical trial data structures, relational databases, and clinical data management processes.
  • Experience handling source data from various systems, including EDC and external vendor data, and transforming them into SDTM-compliant datasets.
  • Strong knowledge of SDTM metadata, mapping specifications, define.xml generation, and data quality review processes.
  • Experience with industry tools such as Pinnacle 21, XML, and Microsoft Office.
  • Knowledge of regulatory requirements and industry standards related to clinical trial submissions.
  • Good understanding of clinical trial methodologies, medical terminology, protocol design, and statistical concepts.
  • Strong communication, collaboration, and problem-solving skills with the ability to work effectively in cross-functional teams.
Preferred Qualifications
  • Experience supporting regulatory submissions such as NDA, BLA, MAA, and other global health authority filings.
  • Knowledge of the drug development lifecycle and global regulatory guidelines.
  • Experience with additional programming languages and tools such as R.
  • Experience working in a Linux/Unix environment.
  • Exposure to automation, process optimization, and standards development initiatives.
Good to Have
  • Experience in ADaM dataset development.
  • Experience in TLF (Tables, Listings, and Figures) programming.
  • Experience supporting submission-ready deliverables and regulatory inspections.
  • Knowledge of advanced reporting and visualization tools used in clinical development.