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Job Description
Structured overview of role & requirementsAbout This Role
Lead statistical programming activities and coordinate programming teams for Phase I-IV clinical trials ensuring timely and quality deliverables for study milestones (e.g., DMCs, IAs, Publications, CSRs, submissions).
Develop, validate, and quality-check datasets, tables, listings, and figures according to specifications and regulatory standards (CDISC SDTM/ADaM, GCP, ICH).
Represent programming function in Clinical Trial Teams and contribute to programming solutions, process improvements, and mentoring junior programmers.
Minimum Requirements
6-10 years of experience in statistical programming within clinical trials.
Strong knowledge of CDISC standards and regulatory frameworks including GCP and ICH.
Proficiency in SAS; R programming proficiency is a plus but not mandatory.
Work Experience Required: 6-10 years in clinical trial statistical programming.
Ideal Candidate Profile
Experienced in leading study-level programming and coordinating cross-functional clinical trial teams.
Strong understanding of regulatory requirements and quality standards ensuring audit readiness and compliance.
Capable of mentoring junior programmers and driving process improvement initiatives.