What are the responsibilities and job description for the Business Analyst Clinical Data position at Promantis Inc?
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