Functional (Business) Analyst

CGI•Fairfax, VA

5d•Hybrid

About The Position

Provides 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.

Requirements

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.

Nice To Haves

Hands on experience with SDTM, ADaM, CDASH, controlled terminology, clinical data validation, data quality review, and conformance assessment.
Experience supporting FDA CoreDF or similar regulatory review systems, reviewer support workflows, or CDER/OCS data management activities.
Working knowledge of DataFit, FDA data quality rules, and automated validation/reporting tools used in study data operations.
Prior experience collaborating with regulatory reviewers, biostatisticians, or data standards governance groups.
Familiarity with SOP development, process mapping, and data governance best practices in regulated environments.

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.