Functional Business Analyst

Functional (Business) AnalystProvides expert level CDISC clinical data standards support to FDA reviewer workflows. Ensures high quality, standards aligned clinical data to improve regulatory review efficiency and strengthen Core Data Fitness deliverables.***This position is located in our Fairfax, VA or Baltimore, MD office; however, a hybrid working model is acceptable***Your future duties and responsibilities:Lead interpretation and application of CDISC standards (SDTM, ADaM, CDASH) for dataset validation, conformance assessment, and structured reporting. Support Core Data Fitness production, including data quality review, analysis readiness checks, metrics development, and reviewer aligned summaries. Deliver clear, structured findings, issue logs, business rules insights, and documentation to FDA reviewers, project managers, and CORs. Collaborate with OCS teams to refine business processes, update SOPs, and improve data governance, quality controls, and reviewer support workflows. Participate in FDA stakeholder sessions to clarify requirements, advance data quality strategies, and enhance standard governed reporting capabilities. Liaise with FDA stakeholders to address data issues, interpret validation results, and support analysis ready dataset provisioning. Support continuous process improvement by contributing to metrics updates, workflow refinements, and alignment across OCS tools and services.Required qualifications to be successful in this role:MS degree plus a minimum of three (3) years of business/systems analysis or quality assurance experience; strong written and verbal communication skills. Familiarity with FDA submission standards, study data reviewer workflows, and structured analytical processes. Knowledge of dataset quality metrics, validation approaches, and structured reporting methods used in regulatory environments. Ability to synthesize technical data issues into clear business focused insights for FDA stakeholders.Skills:Compliance ManagementWhat you can expect from us:Together, as owners, let's turn meaningful insights into action. Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you'll reach your full potential because… You are invited to be an owner from day 1 as we work together to bring our Dream to life. That's why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company's strategy and direction. Your work creates value. You'll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise. You'll shape your career by joining a company built to grow and last. You'll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons. Come join our team—one of the largest IT and business consulting services firms in the world.