Business Analyst Clinical Data

10+ years in IT with 6+ years in Business Analysis for regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with

FDA 21 CFR

Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA, GDPR; experienced in

IQ/OQ/PQ

documentation, SOPs, and audit-ready deliverables Strong domain knowledge in CDM, Biostatistics workflows, CDISC (SDTM/ADaM), FDA eCTD;

Tools:

GitHub Projects, DevOps board, Jira, Power BI, Microsoft Fabric Understanding of Microsoft Fabric, governance policies, compliance documentation; exposure to BI solutions using Power BI Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, advanced analytics (R, Python, SAS), and AI-driven accelerators (WinAIDM) Skilled in stakeholder engagement, workshops, UAT sessions, and cross-functional collaboration Experience defining validation rules, monitoring dashboards, and exception handling processes Experience leveraging GenAI tools (GitHub Copilot, Microsoft Fabric Copilot, M365 Copilot) Bachelor s degree in Life Sciences, Computer Science, or related field