The Junior Programmer/Analyst supports clinical study data imports, transfers, validation, programming, and documentation. Working with Data Management and senior programming staff, this position maintains existing workflows, develops or modifies data-processing programs, supports EDC uploads, and helps ensure that study data and related documentation are accurate, secure, traceable, and compliant with approved requirements.
Primary Duties and Responsibilities
- Prepare, transform, upload, and validate clinical study data from CSV, Excel, XML, JSON, SAS, and other approved formats using the EDC Data Import Manager and related tools.
- Maintain and troubleshoot Python, PowerShell, SQL, Oracle, SQL*Loader, SAS, XML, and other approved programs used for data loading, extraction, transfer, validation, reconciliation, and reporting.
- Develop or modify data-transfer programs and mappings based on approved client specifications and study requirements.
- Create, parse, transform, and validate XML files, schemas, namespaces, and mappings; support applicable CDISC XML formats and system-to-system exchanges.
- Review source and output data for completeness, accuracy, structure, field values, record counts, metadata, and required transformations.
- Develop and execute test cases, investigate discrepancies, perform regression testing, and maintain validation evidence and approvals.
- Review technical specifications, QA packages, testing plans, and study documentation; identify unclear or conflicting requirements and expedite resolution.
- Maintain organize source code, version history, specifications, mappings, schemas, test evidence, troubleshooting notes, and released outputs in approved repositories.
- Use approved AI-assisted development tools for code drafting, explanation, documentation, testing, and troubleshooting. Independently review and validate all AI-generated output and follow organizational AI governance requirements.
- Serve as backup to senior programming staff for routine processing, code maintenance, documentation updates, issue triage, and assigned study workflows.
- Collaborate with Data Management, project teams, clients, vendors, and technical staff; communicate issues, findings, status, and resolutions clearly.
- Follow approved security, privacy, data-retention, change-control, quality, and clinical research procedures, including applicable GCP, electronic-record, data-integrity, and audit-trail expectations.
Required Qualifications
- Bachelor’s degree in computer science, Information Systems, Data Science, Mathematics, Statistics, Data Management, Health Informatics, or a related field; equivalent education, training, or experience may be considered.
- Zero to three years of relevant programming, data analysis, database, data management, or clinical data experience.
- Basic to intermediate proficiency in at least one relevant technology, such as Python, PowerShell, SQL, SAS, XML, or Oracle.
- Working knowledge of structured data, databases, mappings, transformations, testing, and validation concepts.
- Ability to interpret technical specifications and existing code, learn study-specific workflows, and document work accurately.
- Strong attention to detail, analytical and problem-solving skills, organization, communication, and ability to manage multiple priorities.
Preferred Qualifications
- Experience with clinical research data, EDC systems, data imports, vendor transfers, reconciliation, or regulated study workflows.
- Familiarity with XML schemas, XPath, XSLT, CDISC standards, SQL*Loader, APIs, Git, or source-code management.
- Familiarity with testing or quality documentation, GCP, 21 CFR Part 11, data integrity, privacy, and audit trails.
- Experience with approved AI-assisted development tools, with an understanding that all output requires human review and validation.
Working Conditions
The position requires managing multiple priorities in a fast-paced environment and seeking senior technical assistance when appropriate. Occasional work outside normal business hours may be required for critical processing, scheduled transfers, or system implementations.