Data Standardization Specialist III

This role will lead and support data standardization, terminology alignment, metadata definition, and clinical protocol data harmonization activities required to improve the consistency, accuracy, and usability of structured and unstructured clinical trial protocol information., * Lead data standardization activities for clinical trial protocol content, including mapping, harmonization, metadata definition, terminology alignment, and data quality rules.

• Support the development of standardized approaches for extracting information from new ICH M11-compliant structured protocols and historical unstructured protocols.
• Define data elements, metadata attributes, controlled terminology mappings, and normalization rules for protocol domains such as scientific rationale, study design, endpoints, eligibility criteria, safety, study population, interventions, and regulatory compliance.
• Work with clinical SMEs and FDA reviewers to identify critical protocol information required for regulatory review and translate those needs into standardized data structures and extraction specifications.
• Support augmentation of generative AI queries using domain-specific information, conceptual information models, biomedical ontologies, controlled terminologies, and historical protocol content.
• Apply relevant clinical and regulatory data standards from the FDA Data Standards Catalogue and other applicable sources to support protocol review use cases.
• Collaborate with healthcare ontologists to align protocol concepts with biomedical vocabularies, controlled terminologies, and ontology-based representations.
• Support the development of matching and comparison logic to compare incoming and historical protocols by therapeutic area, indication, drug class, study design, endpoints, and other relevant attributes.
• Assist in developing validation criteria, data quality checks, confidence scoring approaches, and human-in-the-loop feedback processes for AI-assisted protocol extraction and comparison.
• Support the design and testing of POC workflows that populate reviewer dashboards and enable protocol interrogation using generative and agentic AI capabilities.
• Participate in analysis of data gaps, inconsistencies, terminology conflicts, missing protocol elements, and standardization challenges.
• Document data standardization processes, assumptions, mappings, validation rules, limitations, and recommended improvements.
• Contribute to project deliverables, including documented extraction processes, comparison algorithms, validation processes, feedback processes, POC documentation, future direction recommendations, and final reports.
• Ensure all work is performed in accordance with FDA security, privacy, confidentiality, non-public information, and contractor training requirements.

Do you have experience in Windows?, Do you have a Bachelor’s degree?, * Bachelor’s degree in Health Informatics, Biomedical Informatics, Computer Science, Data Science, Life Sciences, Public Health, Pharmacy, Clinical Research, or a related discipline.

• 8+ years of experience in data standardization, clinical data management, health informatics, regulatory informatics, biomedical data modeling, or related fields.
• Demonstrated expertise with clinical data standards and controlled terminologies used in regulatory, clinical research, or healthcare environments.
• Strong understanding of clinical trial protocol structure, protocol content, and regulatory review information needs.
• Experience with ICH M11 structured protocol concepts, clinical information modeling, and harmonization of structured and unstructured clinical data.
• Experience mapping clinical or regulatory concepts to controlled terminologies, biomedical ontologies, or standardized data models.
• Knowledge of standards and terminology sources such as CDISC, HL7 FHIR, MedDRA, SNOMED CT, LOINC, RxNorm, UMLS, or similar biomedical vocabularies.
• Experience defining data dictionaries, metadata models, concept maps, data quality rules, and standardization specifications.
• Ability to support AI, NLP, or generative AI teams by translating domain and data standardization requirements into structured prompts, data elements, mappings, and validation criteria.
• Strong analytical skills with the ability to compare complex clinical documents and identify meaningful similarities, differences, and standardization opportunities.
• Strong written and verbal communication skills, including the ability to prepare clear technical documentation and collaborate with FDA stakeholders.
• Ability to work effectively in a multidisciplinary team that includes clinical SMEs, ontologists, data modelers, AI engineers, developers, and project managers.

Preferred Qualifications

• Master’s degree in Biomedical Informatics, Health Informatics, Data Science, Clinical Research, Life Sciences, or a related field.
• Prior experience supporting FDA, HHS, NIH, CMS, or other federal health or regulatory programs.
• Experience with FDA review environments, clinical trial submissions, regulatory data standards, or CDER-related workflows.
• Familiarity with the FDA Data Standards Catalogue and regulatory guidance related to clinical data exchange standards.
• Experience supporting AI-assisted information extraction, RAG, NLP, semantic search, or LLM-based clinical document analysis.
• Familiarity with agentic AI workflows, reviewer dashboards, validation frameworks, and human-in-the-loop feedback processes.
• Experience working with protocol documents in PDF, DOCX, structured templates, or legacy unstructured formats.
• Working knowledge of SQL, Python, JSON, XML, FHIR resources, APIs, or data profiling tools is preferred.
• Experience supporting proof-of-concept development, exploratory projects, and regulatory technology modernization initiatives.

Key Competencies

• Clinical data standardization and harmonization
• ICH M11 structured protocol understanding
• Clinical information modeling
• Biomedical ontology and controlled terminology alignment
• Regulatory data analysis
• AI-assisted extraction support
• Data quality and validation
• Protocol comparison and metadata design
• Cross-functional collaboration
• Clear documentation and technical communication

$140,000 - $145,000 a year - Full-time

BITS is a growing software development company in Washington DC area. We provide database solutions, application development, infrastructure supports, network engineering, and high-end computing using innovative technologies to the health agencies. We are looking for a Data Standardization Specialist III for one of our FEDERAL projects.