Bioinformatics Analyst III

Bioinformatics Analyst III SMX Services & Consulting is seeking a Bioinformatics Analyst III to support the FDA Center for Biologics Evaluation and Research Automation of SDTM/ADaM Content Validation project. The analyst will support the receipt, preparation, loading, validation, review, and reporting of standardized clinical and nonclinical study datasets. The position will work with FDA personnel and subject-matter experts to validate SDTM, ADaM, SEND, and related CDISC-formatted datasets using the FDA's Pinnacle 21 Enterprise and DataFit environment. The analyst must be capable of reviewing automated validation results, comparing reported findings against source datasets, identifying data-quality issues, and preparing accurate findings reports within FDA review timelines. Primary Responsibilities Retrieve clinical and nonclinical submission datasets from FDA-designated repositories. Coordinate dataset intake and processing activities with FDA employees and technical personnel. Prepare and upload SDTM, ADaM, SEND, and sample datasets into Pinnacle 21 Enterprise. Initiate automated dataset validation procedures. Review Pinnacle 21 Enterprise quality reports and validation output. Compare validation findings against the underlying datasets. Identify errors, inconsistencies, anomalies, and potential standards-conformance issues. Support FDA subject-matter experts during the initial review of Pinnacle 21 output. Prepare clear findings reports documenting validation results. Assist with filtering, characterizing, tracking, and reporting validation findings. Support the maintenance and refinement of repeatable clinical-data validation processes. Help document requirements and change requests associated with Pinnacle 21 Enterprise. Support automated validation of FDA applications and clinical-study submissions. Respond to follow-up questions regarding validation reports within one business day. Support initial validation feedback within required FDA timeframes. Maintain accurate records of datasets processed, validation activities, findings, issues, and resolutions. Protect FDA information and Controlled Unclassified Information. Use only FDA-furnished equipment, FDA email, approved VPN access, and FDA-authorized repositories. Complete all required FDA security, privacy, records-management, and role-based training. Required Qualifications United States citizenship. Ability to obtain a Tier 2 Public Trust determination and FDA PIV credential. Education or professional background in bioinformatics, computational biology, biostatistics, health informatics, life sciences, data science, or a related discipline. Demonstrated experience working with structured scientific, clinical, biomedical, or regulatory datasets. Experience reviewing data-validation results and investigating data-quality issues. Understanding of structured data models, metadata, controlled terminology, and validation rules. Ability to review complex technical reports and explain findings clearly. Strong analytical, problem-solving, and documentation skills. Ability to meet time-sensitive FDA submission-review deadlines. Ability to work effectively with government personnel, scientists, data analysts, and technical subject-matter experts. Strong written and verbal communication skills. Preferred Qualifications Experience with Pinnacle 21 Enterprise or Pinnacle 21 Community. Experience with CDISC standards. Experience with SDTM, ADaM, or SEND datasets. Experience supporting FDA, HHS, pharmaceutical, biotechnology, clinical-research, or life-sciences organizations. Familiarity with FDA clinical-data submission and validation processes. Experience preparing clinical-data quality or validation findings reports. Familiarity with NIST, CUI, FISMA, and federal information-security requirements. SMX Services and Consulting, Inc.