Senior Information Technology Specialist - FDA

Serves as the senior technical lead/architect for OCS Data Central modernization and enterprise integration, directing high-level systems engineering, architecture, requirements analysis, technical design, software quality, and modernization roadmaps while ensuring alignment with FDA enterprise architecture, EPLC, security, and operational continuity requirements., * Lead assessment of the existing OCS Data Central architecture and its interfaces with supported reviewer-facing tools (including Analysis Studio where assigned), covering data flows, workflows, integrations, security posture, database performance, technical debt, usability, and modernization opportunities.

• Translate business and regulatory data-management needs into functional/nonfunctional requirements, architecture decisions, technical backlog, release roadmap, and implementation sequencing.

• Design scalable data repository/data warehouse and metadata-management capabilities, including performance, indexing/partitioning, archival, backup/recovery, lineage, and enterprise reporting considerations.

• Lead architecture and engineering for automated study-data discovery/acquisition, orchestration, validation, loading, curation, business-rule execution, quality scoring, exception handling, notifications, and audit logging.

• Define secure integration patterns using REST APIs, database connections, materialized views, batch/streaming mechanisms, message queues, authentication, and secure file exchange as authorized.

• Evaluate cloud readiness, migration strategies, security implications, implementation roadmaps, and cost/risk considerations consistent with FDA direction and enterprise architecture.

• Assess the current Analysis Studio production and migration baseline before prescribing a target architecture. Where the current FDA baseline aligns with the 2024 Analysis Studio 2.0 design, provide technical leadership for .NET user-interface services, the R statistical-computing layer, Docker/Kubernetes deployment, CDER One/cloud integration, and direct OCS Data Central data access. Where legacy components remain, plan controlled coexistence and migration rather than assuming a completed cutover.

• Evaluate AI/advanced analytics opportunities for metadata extraction, document parsing, study-data identification, workflow automation, quality assessment, and reporting automation when directed by FDA.

• Set technical standards for version control, configuration management, automated testing, code quality, documentation, maintainability, scalability, and DevSecOps practices.

• Coordinate with FDA architecture/security organizations, Government Product Owner, OCS stakeholders, OCS Service Desk, and other contractors; resolve interface and dependency issues.

• Support security authorization/ATO-related engineering impacts and ensure technical solutions meet Federal/FDA security requirements.

• Provide senior technical review for defects, root-cause analysis, performance problems, release readiness, and production support of integrated OCS tools/services.

• Mentor developers/IT specialists and provide technical continuity if personnel changes occur.

BS degree in Information Technology or related field. Relevant experience can be substituted for degree requirements., * 10+ years of working experience in all phases of IT application software development, including directing high-level systems engineering, analyzing user needs to determine functional requirements, system design, documentation, implementation, and maintenance of new or existing application software

• Must be able to obtain and maintain a High-Risk Public Trust or equivalent federal client access. This role supports sensitive federal programs and involves elevated access to systems and data.
• Position requires the current ability to obtain and maintain required access without interruption in alignment with long-term program needs.
• Must be authorized to work in the United States without employer sponsorship now or in the future.

PREFERRED QUALIFICATIONS

• Enterprise architecture and systems engineering for data-intensive regulatory applications.

• Modern application/platform engineering spanning .NET and R-based statistical services, Docker/Kubernetes, cloud/container operations, API/data-contract design, observability, and performance/scaling - subject to confirmation of the Government’s current production stack.

• Data warehousing, relational/database performance, metadata management, APIs/integration, workflow orchestration, cloud technologies, and secure software engineering.

• Hands-on ability to review SQL, interfaces, deployment architecture, automated tests, and operational telemetry-not only produce high-level diagrams.

• Knowledge of clinical/nonclinical study-data standards and FDA data-quality context sufficient to design technically appropriate data controls.

• Proposal-strengthening familiarity with Analysis Studio-style clinical review workflows, SDTM/ADaM data provisioning, common analytical data formats (including XPT, RDS, and SAS7BDAT where applicable), reproducible analysis, and reviewer-ready outputs.

• Ability to make architecture tradeoffs visible through decision records, prototypes, performance evidence, and risk analysis.

At APV, we’re more than a technology company - we’re a mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Our expertise spans AI/ML, data architecture, low-code/no-code development, Agile DevSecOps, and cloud services, delivering scalable and meaningful solutions.

In our Emerging Technology Lab, innovation drives progress. Our teams create intelligent chatbots, AI-powered assistants, robotic process automation (RPA), essay graders, and data analytics platforms. If you’re passionate about solving complex challenges and shaping the future, APV is the place for you. Since 2007, we’ve partnered with federal and state agencies to deliver IT, training, and consulting solutions that achieve mission-critical outcomes. Built on accountability, integrity, and quality, we go beyond expectations. With 70+ prime contracts and a proven record of client success, APV continues to grow - and we’re looking for exceptional talent to grow with us.