Principal Statistical Programmer

BANAGALORE , CHENNAI , PUNE  |  Full-time  |  5-15 years

Job Description

  • Review Protocol, CRFs, Annotated CRFs, Statistical Analysis Plan (SAP), and Mock Shells.
  • Develop and validate SDTM domains and ADaM datasets for Safety and Efficacy studies.
  • Develop and validate Tables, Listings & Figures (TLFs) using SAP and Mock Shells.
  • Create and review P21 Validation Reports, Define.xml Packages, and Reviewer Guides (RGs) for CDISC standards.
  • Work independently and collaborate effectively within cross-functional teams.
  • Provide regular status updates to the Study Lead Programmer.
  • Participate in study meetings and support as a Backup Lead.
  • Identify, communicate, and manage study risks and issues.
  • Maintain study documentation in accordance with SOPs and Work Instructions (WI).
  • Contribute to Statistical Programming standards, quality improvements, and process optimization.
  • Stay updated with CDISC standards, GCP, ICH guidelines, and therapeutic area requirements.
  • Mentor and train junior Statistical Programmers.

  • Perform end-to-end clinical programming activities across SDTM, ADaM, TLFs, and R Programming.

    • Skills Required

    SDTM, ADaM, TLF Programming, Safety Programming, Efficacy Programming, Advanced SAS, R Programming, Define.xml, Reviewer Guide, CRF Annotation, CDISC Standards, Clinical Trials Phase I–IV, Therapeutic Area Knowledge, GCP, ICH Guidelines, Study Documentation, Risk Management, Team Collaboration, Mentoring, Regulatory Compliance

    Experience Required

    5-15 years

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