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Vacancy description

Senior Statistical Programmer 1 in Thiruvananthapuram, भारत

Worldwide Clinical Trials

Thiruvananthapuram, भारत

Senior Statistical Programmer leading SAS programming for clinical trial data management and regulatory submissions. Develops CDISC datasets, mentors junior staff, and ensures compliance with regulatory standards across complex studies.

Responsibilities

  • Develop, test, and execute SAS programs for CDISC-compliant datasets and regulatory submissions
  • Review clinical database and TFL specifications; oversee electronic data submission packages
  • Lead programming teams on complex studies; manage timelines, budgets, and resource allocation
  • Provide mentoring and training to junior programmers and cross-functional clinical staff
  • Act as subject matter expert during quality audits and ensure regulatory compliance (FDA, GDPR)

Requirements

  • Degree-level education or equivalent qualification
  • Advanced SAS expertise including Macro, Proc Report, and ODS programming
  • Minimum 4 years of related statistical programming experience
  • Expert-level knowledge in CDISC SDTM and ADaM dataset development
  • Strong analytical skills with meticulous attention to detail
  • Experience leading programming teams on complex clinical studies

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