Software Architect

The Biostatistics Center of the Milken Institute School of Public Health is an off-campus research facility of The George Washington University located in Bethesda, Maryland. The Center serves as the coordinating center for large-scale multi-center clinical trials and epidemiological studies funded by federal agencies including the National Institutes of Health (NIH). It is a leader in the statistical coordination of major medical research programs of national and international scope.

About the Role

Employees in the Enterprise Systems Development subfamily develop, troubleshoot, design modifications, and upgrade enterprise systems software. This Software Architect position is an expert-level individual contributor responsible for the design, development, enhancement, and ongoing support of the Center’s in-house developed clinical data entry and management system called MIDAS. MIDAS captures, validates, stores, and reports participant data across the Center’s clinical trials and epidemiological studies.

This role works on MIDAS and its successor releases, adhering to the BSCOIT (Biostatistics Center Office of Information Technology) software development life cycle (SDLC) and associated procedures governing application development. As a Level IV (Expert) contributor, the Software Architect handles the most technically complex and highest-risk components, exercising independent judgment and technical authority over deliverables. The position resolves difficult technical problems, sets engineering and quality standards, and maintains deep expertise in the system’s codebase, data model, and regulatory dependencies.

Responsibilities

• Serve as the senior technical developer and subject matter expert for the Center’s clinical data entry and management system (MIDAS).
• Design and deliver the most complex and highest-risk development work, producing high-quality, well-architected solutions.
• Plan, design, and develop complex features and enhancements for MIDAS using appropriate tools and techniques to resolve difficult technical problems.
• Ensure all work aligns with established system design and meets requirements for quality, security, data integrity, maintainability, and extensibility.
• Translate functional, regulatory, and protocol requirements into technical designs and specifications.
• Implement, patch, and upgrade the application and its components, processing changes through the Center’s change control and validation procedures for clinical data software.
• Code and test software in accordance with SDLC and clinical data programming standards, preparing solutions for release following defined promotion, validation, and deployment procedures.
• Design and implement controls for regulated clinical data systems, including role-based access, electronic signatures, and complete audit trails.
• Adhere to the Center’s policy on generative AI in software development, ensuring mandatory human review, dependency verification, and static analysis before code acceptance.
• Uphold Center coding standards and secure development practices, participating in code reviews as both author and reviewer.
• Troubleshoot and resolve the most difficult defects and production issues, including support for local and remote users at clinical sites.
• Document developed software and maintain accurate technical, validation, and user-facing documentation.
• Participate in requirements, verification, and testing sessions, communicating technical concepts clearly.
• Stay updated on the latest technologies and best practices, propagating innovation within the division.
• Provide technology-related advice and recommendations for projects, demands, and operations.
• Assist in coaching and training stakeholders on technical matters.
• Perform other duties as assigned, with project assignments and priorities communicated through the supervisor.

Requirements

• Bachelor’s degree in a relevant field plus 7 years of professional experience, or a Master’s degree or higher plus 5 years of professional experience. Degree must be conferred by the start date.
• Degree requirements may be substituted with an equivalent combination of education, training, and experience.

Preferred Qualifications

• Expert-level technical background and strong information technology skills.
• Extensive experience in software and application design and architecture, including ownership of large, complex applications across multiple release cycles.
• Strong software development and coding experience in object-oriented languages such as Java, with related web technologies (JavaScript, HTML, CSS) and frameworks (e.g., OSGi, Spring, Struts, Vue).
• Experience designing and developing complex Windows-based and Linux-based systems, web applications, and batch applications.
• Strong knowledge of relational databases and database programming, with the ability to design data models supporting data integrity and reporting.
• Understanding of software quality assurance, secure development, and computer system validation principles.
• Working knowledge of standards governing clinical data systems (21 CFR Part 11, ICH GCP, ALCOA data integrity, CDISC) or the ability to quickly acquire and apply them.
• Ability to work within a defined SDLC, including disciplined change control, validation, code review, and documentation requirements.
• Demonstrated ability to work independently as an expert-level developer, owning complex technical work and serving as a deep technical authority.
• Technical and innovative mindset with strong attention to detail and outstanding written and verbal communication.
• Direct experience developing or maintaining a clinical data management, electronic data capture (EDC), or electronic case report form (eCRF) system in a regulated environment.
• Experience with a coordinating center, contract research organization, or sponsor data management environment.
• Experience migrating monolithic applications toward a service-oriented architecture.
• Experience with static analysis tools, dependency management, and automated testing in a validated development environment.
• Familiarity with statistical or data tools such as SAS, R, Python, or SQL used downstream of the data system.

Pay

$113,891.62 - $222,341.50

Benefits

GW offers a comprehensive benefits package, including:

• Medical, dental, vision, life, and disability insurance.
• Time off and leave.
• Retirement savings.
• Tuition benefits.
• Well-being programs.
• Various voluntary benefits.

For program details and eligibility, visit https://hr.gwu.edu/benefits-programs.

Schedule

• Full-time, 40 hours per week.
• Monday–Friday, 9:00 AM–6:00 PM.
• Hybrid work arrangement.
• On-site requirement: Yes (Rockville, Maryland).