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Tier-1 CRO, metro Hyderabad, and senior-level role create moderate competition given niche CDISC/SAS specialization.
Strong domain dependency on clinical trials, CDISC, and SAS makes cross-industry transfer limited.
Explicit 6–10 years, mandatory CDISC/SAS skills, and regulatory compliance raise strictness.
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Lead and coordinate statistical programming activities for clinical trials across Phases I to IV, ensuring quality and timely deliverables for study milestones such as DMCs, IAs, publications, and submissions.
Develop, validate, and quality check datasets, tables, listings, and figures according to specifications, adhering to company, departmental, industry standards, and regulatory compliance (e.g., CDISC SDTM/ADaM, GCP).
Mentor junior programmers and contribute to process improvements, while maintaining effective communication with cross-functional teams and representing programming in Clinical Trial Teams if performing the technical programming role.
6-10 years of experience in statistical programming for clinical trials.
Proficiency in SAS; knowledge of R and/or Python is a plus but not mandatory.
Strong knowledge of CDISC standards and regulatory frameworks including GCP and ICH guidelines.
Work Experience Required: 6-10 years in related statistical programming roles. Notice Period: Not explicitly mentioned in the JD.
Experienced in leading programming teams and coordinating multi-study or project-level programming activities with proven delivery of quality outputs.
Demonstrates strong expertise in CDISC and regulatory requirements applicable to clinical trial programming.
Operates effectively in cross-functional clinical trial environments, capable of mentoring juniors and contributing to process standardization and improvements.