Sr Business Analyst - Clinical

San R&D Business Solutions LLC•Raleigh, NC

1d•Onsite

About The Position

The Business Analyst acts as the bridge between clinical stakeholders and technical teams, ensuring requirements are captured, translated, and delivered effectively. The ideal candidate should lead requirement gathering and 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.

Requirements

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.
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.
Understanding the Microsoft Fabric.
Good in understanding governance policies, compliance documentation.
Exposure BI solutions using Power BI
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.
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.
6+ years of experience facilitating workshops, UAT sessions, and cross-functional collaboration.
Strong ability to translate technical concepts into business language for diverse stakeholders.
Hands-on experience defining validation rules, monitoring dashboards, and exception handling processes.
Skilled in ensuring data completeness, accuracy, and traceability across the lifecycle.
Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, and advanced analytics (R, Python, SAS).
Familiarity with AI-driven accelerators (WinAIDM, Fabric Copilot) for metadata-driven pipeline development and compliance automation.
Hands-on experience leveraging GenAI tools (GitHub Copilot, Microsoft Fabric Copilot, M365 Copilot) to accelerate the documentation and requirements gathering and other project needs.
Communicate effectively with CDM, Biostatistics, IT, and vendor stakeholders.
Use clear verbal, written (emails, documentation), and instant messaging approaches to ensure alignment.
Build and maintain productive relationships across cross-functional teams.
Provide constructive feedback during requirement workshops and be open to stakeholder input.
Strong analytical mindset to evaluate complex clinical data workflows.
Ability to troubleshoot requirement gaps, compliance risks, and process inefficiencies.
Prior experience working in Agile/Scrum projects with tools like Jira or Azure DevOps.
Provide regular updates, demonstrate proactivity, and show due diligence in carrying out responsibilities.
Skilled in facilitating workshops, UAT sessions, and requirement walkthroughs.
Act as liaison between business and technical teams, ensuring clarity and consensus.

Nice To Haves

Deeper knowledge of clinical data flows, CDISC standards (SDTM/ADaM), and regulatory submission processes (FDA eCTD).
Familiarity with biostatistics workflows and vendor data exchange practices.
Awareness of AI-driven accelerators (WinAIDM, Fabric Copilot) for metadata-driven documentation and compliance automation.
Exposure to advanced analytics trends such as real-world evidence (RWE) and predictive modeling in clinical trials
Business Analysis certifications such as CBAP (Certified Business Analysis Professional), PMI-PBA, or IIBA.
Exposure to Microsoft certifications relevant to data and analytics (e.g., DP-600 Fabric Analytics Engineer, DP-203 Azure Data Engineer).

Responsibilities

Lead requirement gathering sessions with CDM, Biostatistics, and vendor stakeholders.
Translate regulatory and business needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA.
Document user stories, acceptance criteria, and workflows for ingestion, validation, and reporting.
Author Business Requirement Documents (BRD) and Functional Requirement Specifications (FRS).
Define validation rules across Bronze, Silver, and Gold layers (schema, business rules, certification).
Ensure requirements incorporate dataset versioning, lineage, audit trails, and electronic signatures.
Collaborate with QA teams to support IQ/OQ/PQ validation documentation and SOP creation.
Support compliance reviews and FDA/EMA inspection readiness.
Capture reporting requirements for Power BI dashboards, compliance scorecards, and study progress reports.
Define business rules for secure analytics environments (Python, R, SAS integration).
Partner with technical teams to ensure reporting aligns with governance and audit workflows.
Facilitate workshops, UAT sessions, and requirement walkthroughs with CDM, Biostatistics, and IT teams.
Act as liaison between business stakeholders and technical delivery teams.
Drive milestone sign-offs for requirement validation, UAT completion, and compliance readiness.
Define secure vendor data exchange requirements (SFTP, portals, audit logging).
Monitor data quality dashboards and coordinate issue resolution.
Ensure requirements support scalability (100+ users, TB-scale datasets) and performance benchmarks.
Contribute to roadmap planning for CDISC/SDTM/ADaM integration, OMOP mapping, and advanced analytics.
Capture evolving requirements for AI-driven insights and real-world evidence (RWE) integration.