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Tier-1 brand, mid-level seniority, and metro Hyderabad raise competition to medium.
Strong CDISC, SAS, and clinical-regulatory requirements limit transferability outside pharma/CRO settings.
Explicit 6-10 years plus mandatory CDISC/SAS and regulatory requirements make screening strict.
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Lead statistical programming activities for Phase I-IV clinical trials, ensuring timely and accurate deliverables across study milestones such as DMCs, IAs, publications, CSRs, and regulatory submissions.
Develop, validate, and perform quality control on datasets, tables, listings, and figures (TFLs) according to specifications and regulatory standards (CDISC SDTM/ADaM, GCP).
Coordinate and mentor junior programmers, participate in cross-functional team communications, and contribute to process improvements and programming standards at study and project levels.
6-10 years of experience in statistical programming within clinical trial context.
Proficiency in SAS required; proficiency in R programming considered an advantage.
Strong knowledge of CDISC standards and regulatory frameworks including GCP and ICH guidelines.
Work Experience Required: 6-10 years
Experienced in leading programming teams and managing complex deliverables for clinical trials across multiple phases.
Expertise in regulatory compliance and applying industry programming standards effectively to ensure audit readiness.
Able to coordinate with cross-functional teams and provide guidance to junior programmers, contributing to process standardization and improvement projects.