Functional Business Analyst Expert

Functional Business Analyst Expert Job Description

Position Title: Functional Business Analyst Expert
Project: Core Data Fitness (CoreDF) Program
Employment Type: Full-Time

Position Summary

The Functional Business Analyst Expert will support the Core Data Fitness (CoreDF) initiative for the Office of Computational Science (OCS) under the Center for Drug Evaluation and Research (CDER) at the FDA. The role focuses on gathering business requirements analyzing clinical and non-clinical data validation processes supporting reporting operations coordinating stakeholder communication and driving continuous process improvements for regulatory data review activities.

The analyst will work closely with reviewers project managers technical teams and FDA stakeholders to support DataFit validation reporting improve reporting workflows collect enhancement requirements manage documentation and support Agile-based implementation efforts across multiple FDA offices.

Key Responsibilities

• Gather analyze document and validate business and functional requirements for CoreDF reporting solutions.
• Work with clinical and non-clinical reviewer groups to identify reporting enhancements and validation needs.
• Support DataFit validation and reporting processes for SDTM and SEND regulatory datasets.
• Coordinate report generation report delivery scheduling and stakeholder communication activities.
• Facilitate meetings stakeholder discussions project reviews and requirement workshops.
• Prepare business process documents SOPs user guides workflow diagrams and project artifacts.
• Collaborate with technical teams and report developers to implement new reporting capabilities.
• Support Agile processes for collecting piloting and implementing new requirements from FDA offices and centers.
• Analyze metrics reporting trends and operational data to improve process efficiency and service delivery.
• Track project risks issues status updates and performance metrics for leadership reporting.
• Assist with continuous improvement initiatives and recommendations for DataFit output reporting enhancements.
• Support reviewers and analysts with report usage issue resolution and delivery platform assistance.
• Ensure all deliverables comply with FDA standards documentation practices and Section 508 accessibility requirements.
• Participate in project management activities including status reporting release documentation and change management support.

Required Qualifications

• Bachelor s degree in Business Administration Information Systems Computer Science Health Sciences Life Sciences or related field.
• 8 years of experience as a Business Analyst or Functional Analyst in federal or healthcare IT environments.
• Strong experience gathering and documenting business and functional requirements.
• Experience working with Agile methodologies and SDLC processes.
• Knowledge of clinical or regulatory data standards such as SDTM and SEND.
• Experience supporting reporting analytics validation or data quality initiatives.
• Strong communication and stakeholder management skills.
• Experience preparing project documentation meeting materials SOPs and status reports.
• Ability to coordinate cross-functional teams and communicate with technical and non-technical stakeholders.
• Proficiency with Microsoft Office Suite SharePoint and reporting/documentation tools.

Preferred Qualifications

• Prior experience supporting U.S. Food and Drug Administration CDER NIH HHS or other federal healthcare agencies.
• Familiarity with DataFit or similar clinical data validation/reporting platforms.
• Experience supporting pharmaceutical biotech clinical research or regulatory review environments.
• Knowledge of FDA review processes and compliance standards.
• Experience with metrics reporting process improvement and operational analytics.
• PMP CBAP PMI-PBA or Agile certification preferred.

Key Skills

• Business Analysis
• Functional Requirements Gathering
• Regulatory Data Analysis
• SDTM / SEND Validation
• Agile Methodology
• Stakeholder Management
• Process Improvement
• Reporting & Metrics Analysis
• Documentation & SOP Development
• Data Quality & Validation
• Project Coordination
• FDA / Federal Healthcare Environment