Analyst, Plano, TX, Maplegrove, MN
Role Summary
The Principal Clinical Information Analyst is a senior-level individual contributor responsible for leading the design, development, optimization, governance, and strategic evolution of clinical trial reporting and analytics solutions. This role serves as a trusted advisor and subject matter expert for clinical operations, study management, site management, data review, safety, and other shared service functions. The Principal Clinical Information Analyst works under Good Clinical Practices, Good Clinical Data Management Practices, and applicable regulatory guidelines. The role requires strong judgment, technical depth, executive communication skills, and the ability to operate effectively across multiple levels of the organization.
Key Responsibilities
• Lead cross-functional discovery with Site Management, Study Management, Data Review, Safety, Clinical Operations, Data Management, and other stakeholders to define operational, analytical, study-specific, and portfolio-level reporting needs.
• Translate ambiguous business questions into clear analytical requirements, reporting specifications, data definitions, acceptance criteria, and scalable solution designs.
• Serve as a senior subject matter expert for clinical reporting strategy, metric definitions, reporting conventions, data interpretation, and best practices.
• Design, develop, validate, and maintain complex reporting solutions using Oracle RDBMS, advanced SQL, Power BI, SSRS, and related analytics tools.
• Own end-to-end delivery of reporting solutions, including requirements intake, design, build, testing, validation, deployment, documentation, user enablement, lifecycle support, and continuous improvement.
• Create scalable and reusable reporting assets, including data models, semantic layers, dashboards, templates, standard queries, reporting libraries, and metric frameworks.
• Proactively assess stakeholder requests, identify risks or gaps, challenge assumptions when appropriate, and recommend solutions that improve quality, usability, scalability, and decision-making.
• Provide advanced analytical interpretation and actionable insights to clinical operations leaders, study teams, and functional stakeholders.
Required Qualifications
• Bachelor’s degree, or an equivalent combination of education and work experience.
• Minimum 10 years of related experience in clinical research, clinical operations reporting, clinical data analytics, healthcare analytics, business intelligence, or a closely related regulated environment.
• Advanced experience developing reporting and analytics solutions using SQL with Oracle RDBMS, including complex queries, data validation, troubleshooting, and performance-conscious design.
• Strong experience designing, developing, and maintaining business intelligence solutions using Power BI and/or SSRS, including dashboards, reports, visualizations, and recurring operational reporting.
• Demonstrated ability to independently lead end-to-end reporting solutions, challenge assumptions, guide stakeholders, and translate ambiguous clinical or operational needs into scalable reporting products.
Preferred Qualifications
• Bachelor’s or Master’s degree in Business Administration, Data Science, Statistics, Computer Science, Health Informatics, Life Sciences, Clinical Research, or a related field.
• Deep experience in pharmaceutical, biotech, CRO, medical device, academic research, or regulated healthcare environments supporting clinical trial operations, clinical data review, or study performance reporting.
• Advanced Power BI experience, including data modeling, DAX, Power Query, semantic model design, report optimization, user experience design, and governed self-service reporting; experience with Tableau is a plus.
• Experience establishing or improving reporting standards, metric definitions, data dictionaries, validation practices, reusable templates, reporting conventions, or analytics governance processes.
• Experience mentoring analysts, reviewing technical deliverables, training end users, influencing cross-functional stakeholders, and presenting insights or recommendations to clinical operations leaders or senior leadership.
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