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Job Title: Sr Business Analyst
Location: Raleigh, NC (On-site)
Duration: open for Contract
Educational Qualification*
Bachelor’s degree in Life Sciences, Computer Science, or related field
Experience Range
10-12 years of experience in Business Analysis within Clinical Data Management or Biostatistics domain
Tagline/Tech Stack Snapshot -
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
Role Summary - (To be filled by Practice /DO)
1. Business Analyst acts as the bridge between clinical stakeholders and technical teams, ensuring requirements are captured, translated, and delivered effectively.
2. Leads requirement gathering & documentation across CDM, Biostatistics, and vendor partners.
3. Translates business and regulatory needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA.
4. Supports validation frameworks, audit-ready documentation, and reporting requirements such as Power BI dashboards and compliance scorecards.
5. Facilitates workshops, UAT sessions, and milestone sign-offs to secure stakeholder alignment.
6. Prepares for future readiness , advanced analytics, and AI-driven insights.
Primary (Must have skills)* - To be Screened by TA Team
1.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.
2.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.
3.Microsoft Fabric & Data Governance –Understanding the  Microsoft Fabric. Good in understanding governance policies, compliance documentation.
4.Power BI & Reporting – Exposiure  BI solutions using Power BI
5.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.
6.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.
7.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.
8.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.
9.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.
10. 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.
Why This Role Matters - New addition (To be filled by Practice /DO)
The Business Analyst is the bridge between clinical stakeholders and technical delivery teams, ensuring that the Clinical Data Repository is not only implemented but also aligned with regulatory, operational, and analytical needs. In a highly regulated environment like Life Sciences and Pharma, success depends on translating complex CDM and Biostatistics requirements into actionable, compliant solutions.
This role matters because:
• It ensures regulatory confidence by embedding 21 CFR Part 11, GxP, and HIPAA compliance into every requirement.
• It drives operational efficiency by reducing manual data transfers, enabling secure vendor collaboration, and standardizing workflows.
• It enables analytics readiness by defining requirements for dashboards, scorecards, and validated pipelines in Microsoft Fabric and Power BI.
• It fosters stakeholder alignment by facilitating workshops, UAT sessions, and milestone sign-offs across CDM, Biostatistics, IT, and vendors.
• It lays the foundation for innovation, preparing the organization for CDISC/OMOP integration, advanced analytics, and AI-driven insights in future phases
What You'll Do/
Job Description of Role* (RNR) - To be Evaluated by Technical Panel (Define it to give more clarity)
Requirements Analysis & Translation
• 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).
Data Governance & Compliance
• 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.
Analytics & Reporting Enablement
• 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.
Stakeholder Engagement & Delivery
• 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.
Operational Oversight & Vendor Collaboration
• 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.
Future Readiness
• 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.
Soft skills/other skills - To be Evaluated by Hiring Manager (To define how this will be evaluated)
Communication Skills
• Communicate effectively with CDM, Biostatistics, IT, and vendor stakeholders.
• Use clear verbal, written (emails, documentation), and instant messaging approaches to ensure alignment.
Interpersonal Skills
• Build and maintain productive relationships across cross-functional teams.
• Provide constructive feedback during requirement workshops and be open to stakeholder input.
Problem-Solving & Analytical Thinking
• Strong analytical mindset to evaluate complex clinical data workflows.
• Ability to troubleshoot requirement gaps, compliance risks, and process inefficiencies.
Task / Work Updates
• 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.
Stakeholder Management
• Skilled in facilitating workshops, UAT sessions, and requirement walkthroughs.
• Act as liaison between business and technical teams, ensuring clarity and consensus.
What Success Looks Like (6–12 Months) -
Expected Outcome
We are looking for a seasoned Business Analyst with 10+ years of experience in requirement analysis and delivery of data & analytics solutions for regulated industries (Life Sciences / Pharma). The ideal candidate will drive requirement gathering, compliance alignment, and stakeholder engagement for a GxP-compliant, cloud-native data platform on Microsoft Fabric and Azure. Success will be measured by the ability to translate CDM/Biostatistics needs into validated pipelines, dashboards, and audit-ready documentation.
Expected Outcomes (6–12 Months):
• Phase 1 Clinical Data Repository delivered within 16–18 weeks.
• Requirements translated into compliant workflows and validated pipelines.
• Audit-ready documentation (IQ/OQ/PQ, SOPs, lineage, validation rules) completed.
• Power BI dashboards and compliance scorecards actively used by stakeholders.
• Improved collaboration across CDM, Biostatistics, IT, and vendors.
• Foundation established for Phase 2 (CDISC/OMOP integration, advanced analytics, AI-driven insights).
Secondary Skills  (Good to have)
Life Sciences Domain Knowledge
• Deeper knowledge of clinical data flows, CDISC standards (SDTM/A

Thanks & Regards

Ash Kumar

Client Engagement Partner

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