Job Description

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.