SDTM Programmer

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 45 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.
• 710 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.