Business Analyst – Clinical Data & Analytics

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Job Title - Business Analyst – Clinical Data & Analytics

Location - San Jose, CA - Onsite

Role Summary

• Business Analyst acts as the bridge between clinical stakeholders and technical teams, ensuring requirements are captured, translated, and delivered effectively.
• Leads requirement gathering & documentation across CDM, Biostatistics, and vendor partners.
• Translates business and regulatory needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA.
• Supports validation frameworks, audit-ready documentation, and reporting requirements such as Power BI dashboards and compliance scorecards.
• Facilitates workshops, UAT sessions, and milestone sign-offs to secure stakeholder alignment.
• Prepares for future readiness , advanced analytics, and AI-driven insights.
  
  

Experience Range - 10-12 years of experience in Business Analysis within Clinical Data Management or Biostatistics domain

Business Analyst – Clinical Data & Analytics

Domain Knowledge – Clinical Data Management (CDM), Biostatistics workflows, CDISC (SDTM/ADaM), FDA eCTD.

Collaboration Tools – Github Projects / DevOps board / Jira

Power BI

Fabric Data Platform

Must have skills –

• Overall Experience – 10 years in IT with the most recent 6 years focused on Business Analysis in regulated environments (Life Sciences, Pharma, Healthcare). Demonstrated success in translating complex clinical and biostatistics requirements into compliant, analytics-ready solutions.
• Business Analysis & Requirement Translation – 6 years of experience gathering, documenting, and validating requirements from Clinical Data Management (CDM) and Biostatistics teams. Proven ability to conduct workshops, create functional specifications, and ensure alignment with FDA 21 CFR Part 11, GxP, and HIPAA compliance.
• Microsoft Fabric & Data Governance –Understanding the Microsoft Fabric. Good in understanding governance policies, compliance documentation.
• Power BI & Reporting – Exposiure BI solutions using Power BI
• Clinical Data Management (CDM) & Biostatistics Collaboration – Strong domain knowledge in clinical trial data workflows, vendor data exchange, and biostatistics validation. Skilled in bridging CDM and Biostatistics requirements into unified, governed repositories.
• Compliance & Validation – Good understanding of regulatory frameworks including 21 CFR Part 11, GxP validation, HIPAA, and GDPR. Experienced in preparing IQ/OQ/PQ documentation, SOPs, and audit-ready deliverables.
• Stakeholder Engagement & Communication – 6 years of experience facilitating workshops, UAT sessions, and cross-functional collaboration. Strong ability to translate technical concepts into business language for diverse stakeholders.
• Data Quality & Monitoring – Hands-on experience defining validation rules, monitoring dashboards, and exception handling processes. Skilled in ensuring data completeness, accuracy, and traceability across the lifecycle.
• Future-Ready Skills – Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, and advanced analytics (R, Python, SAS). Familiarity with AI-driven accelerators (WinAIDM) for metadata-driven pipeline development and compliance automation.
• Generative AI / Copilot- Hands-on experience leveraging GenAI tools (GitHub Copilot, Microsoft Fabric Copilot, M365 Copilot) to accelerate the documentation and requirements gathering and other project needs.