Job Title: Clinical Data Standards Analyst III
Alternative Government Workbook Title: Clinical Data Standards Specialist III
Request ID: RFQ1826464
Project: CBER CASA-CV Support
Location: Washington, DC metropolitan area, including Rockville, Silver Spring, and Beltsville, Maryland
Work Arrangement: Local hybrid position. Remote work may be authorized by FDA, but the employee must be available for onsite meetings and activities when directed.
Schedule: Monday through Friday, generally 8:30 AM-5:00 PM Eastern Time
Travel: Local DC metropolitan travel may be required and is not separately reimbursable
Citizenship: Must be a United States citizen
Security Requirement: Must be able to obtain a Tier 2 Public Trust background determination and HSPD-12 PIV credential
Compensation
T
arget Candidate Pay Rate: $56.32-$58.16 per hourPosition Summary
The analyst will provide subject-matter expertise involving CDISC standards, including SDTM, ADaM, and SEND. The position will assist with loading standardized datasets into Pinnacle 21 Enterprise, reviewing validation output, confirming findings against source data, and preparing accurate findings reports for FDA reviewers.
The ideal candidate will understand both the technical structure of standardized datasets and the regulatory purpose of data-validation rules.
Primary Responsibilities
- Support the intake, preparation, and validation of SDTM, ADaM, SEND, and related standardized datasets.
- Retrieve datasets from FDA-authorized repositories.
- Upload and configure datasets for processing in Pinnacle 21 Enterprise.
- Initiate validation processes using the FDA DataFit/Pinnacle 21 environment.
- Review Pinnacle 21 validation reports, warnings, errors, and informational findings.
- Determine whether reported findings reflect actual data-quality or standards-conformance issues.
- Compare validation output against source datasets, metadata, controlled terminology, and applicable implementation guides.
- Work with FDA employees and subject-matter experts to review validation findings.
- Prepare findings reports that clearly describe issues and supporting evidence.
- Track, characterize, filter, and report validation findings.
- Support the maintenance of formal and repeatable clinical-data validation processes.
- Assist with Pinnacle 21 change requests, business requirements, and validation-rule updates.
- Support automated validation requirements for FDA applications.
- Help develop procedures, checklists, data-validation guidance, and training materials.
- Respond to follow-up questions concerning validation reports within one business day.
- Support initial or updated validation feedback within required FDA turnaround times.
- Participate in technical, data-validation, and process-improvement meetings.
- Maintain accurate validation records and version-controlled documentation.
- Identify recurring data-quality issues and recommend process improvements.
- Support the annual goal of improving efficiency and reducing O&M effort.
- Protect CUI and non-public FDA information.
- Perform all work using FDA-authorized systems, equipment, email, VPN, and repositories.
Required Qualifications
- United States citizenship.
- Ability to obtain a Tier 2 Public Trust determination and FDA PIV credential.
- Demonstrated professional experience with clinical-data standards or structured regulatory datasets.
- Knowledge of CDISC standards and implementation concepts.
- Experience interpreting data-validation rules, warnings, errors, and conformance findings.
- Ability to inspect datasets and determine the cause of validation findings.
- Understanding of metadata, controlled terminology, data domains, variables, and submission structures.
- Strong analytical and problem-solving skills.
- Ability to document technical findings clearly for both technical and nontechnical reviewers.
- Ability to work within strict regulatory review deadlines.
- Strong written and verbal communication skills.
- Ability to work collaboratively with scientists, reviewers, statisticians, programmers, analysts, and government personnel.
Preferred Qualifications
- Direct experience with Pinnacle 21 Enterprise or Pinnacle 21 Community.
- Direct experience with SDTM.
- Direct experience with ADaM.
- Direct experience with SEND.
- Familiarity with define.xml and related submission metadata.
- Experience supporting FDA regulatory submissions or clinical-study review.
- Experience in the pharmaceutical, biotechnology, clinical-research, medical-device, biologics, or public-health sectors.
- Experience developing CDISC validation specifications, procedures, or training.
- Familiarity with FDA Technical Conformance Guides and applicable CDISC implementation guides.
- Familiarity with federal information-security, CUI, and records-management requirements.
