Functional (Business) Analyst

CGI Njoyn; Fairfax (VA); Hybrid; USD 80,000 - 157,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive insurance options

Matching contributions through 401(k)

Paid time off

Paid parental leave

Tuition assistance

Wellness programs

Job summary

CGI is seeking a Functional (Business) Analyst in Fairfax, VA (hybrid). You will provide expert CDISC standards support to FDA reviewer workflows and contribute to Core Data Fitness deliverables.

Responsibilities include leading SDTM/ADaM/CDASH interpretation, data quality reviews, and documenting findings for FDA reviewers and project managers while collaborating with OCS to align data governance and reviewer support processes.

Qualifications

• MS degree required with minimum 3 years of business/systems analysis or quality assurance experience.
• 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.

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.

Skills

Business/Systems Analysis

Quality Assurance

Regulatory processes

Education

MS degree

Tools

DataFit

Job description

Job order - J0926-1056 - Permanent Full Time

Functional (Business) Analyst

Business Analysis (functional and technical)

Fairfax, Virginia, United States

Position Description

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

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.

Desired qualifications/non essential skills required

• 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.

CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $79,600.00 $156,700.00.

Benefits

• Competitive compensation
• Comprehensive insurance options
• Matching contributions through the 401(k) plan and the share purchase plan
• Paid time off for vacation, holidays, and sick time
• Paid parental leave
• Learning opportunities and tuition assistance
• Wellness and Well being programs

Company Culture

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.

Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status or responsibilities, reproductive health decisions, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics to the extent required by applicable federal, state, and/or local laws where we do business.

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at [e-mail] . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned.

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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.