Principal Statistical Programmer

• 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 IIV, Therapeutic Area Knowledge, GCP, ICH Guidelines, Study Documentation, Risk Management, Team Collaboration, Mentoring, Regulatory Compliance

Experience Required

5-15 years

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