Associate Director, Open-Source Application Development

About the role

Everest Clinical Research is seeking a committed, skilled, and customer-focused individual to join our winning team as an Associate Director, Open-Source Application Development. This position is remote or in-office.

Responsibilities

• Provide leadership and expertise in defining, implementing, and governing Everest's open-source application development strategy in support of clinical data standards, statistical programming, and analytics.
• Design, write, test, and maintain production-quality SAS, R, and Python code (functions, packages, APIs, and utilities), serving as a hands-on technical contributor and lead developer on priority applications.
• Ensure alignment with global regulatory expectations and evolving guidance related to data standards (e.g., CDISC), automation, and advanced analytics as reflected in internally developed tools and applications.
• Oversee the design, development, and maintenance of SAS-, R-, and Python-based applications, packages, and utilities that support metadata-driven data models for automation of downstream clinical data activities.
• Personally architect and build core modules, reusable functions, and internal libraries/packages ensuring clean, modular, well-documented, and maintainable code.
• Conduct in-depth code reviews and code review programming sessions with programmers and developers to raise coding quality, enforce Everest style guides, and mentor others in software engineering best practices.
• Develop and maintain CI/CD pipelines (e.g., GitHub Actions) to automate testing, linting, package building, and deployment of applications and tools.
• Identify opportunities to streamline workflows, reduce manual effort, and eliminate redundancies through custom-built, standardized, and automated application solutions spanning SAS and open-source environments.
• Prototype and build proof-of-concept tools and scripts to evaluate new packages, frameworks, libraries, or AI-assisted coding approaches before broader adoption.
• Debug, troubleshoot, and resolve technical issues in existing applications, including performance optimization, dependency management, and environment/configuration issues.
• Establish a framework that supports controlled innovation in application development and validation lifecycle, including design specifications, coding standards, coding review, version control, change management, and impact assessment for new applications/tools and their releases.
• Ensure AI-assisted development approaches align with regulatory expectations, data integrity principles, and Everest validation and documentation requirements.
• Maintain a software development lifecycle (SDLC) framework appropriate for open-source language-based applications, including source control practices (e.g., GitHub or similar), branching strategy, testing standards, and release management.
• Maintain deep proficiency in SAS programming (Base SAS, SAS/STAT, macro language) to support legacy systems, hybrid SAS/R/Python workflows, and interoperability across statistical programming environments during the transition to open-source tools.
• Foster a culture that balances quality, compliance, and operational excellence with thoughtful innovation in application development.

Qualifications and Experience

• A M.Sc., M.A. or higher in Statistics, Computer Science, or a relevant field with at least 10 years of clinical research and industry experience.
• Demonstrated experience implementing CDISC standards for various therapeutic areas and supporting regulatory submissions of clinical trial data.
• Strong hands-on experience with R, Python, and SQL, including application development (not limited to scripting/analysis), package/library creation, and software design for clinical data and statistical programming use cases.
• Demonstrated experience applying AI and large language model (LLM) tools for coding development, including code generation, code review, testing, and integration into applications/tools.
• Experience with GitHub or similar version control and application development platforms (e.g., GitLab, Bitbucket), including code review workflows, branching strategies, and continuous integration/continuous deployment (CI/CD).
• Experience deploying and supporting applications in cloud and containerized environments (e.g., AWS, Azure, or GCP; Docker; Kubernetes), including exposure to hosting/deployment platforms such as Posit Connect, Shiny Server, or equivalent.
• Experience with developing and delivering training curricula is preferred.
• In-depth knowledge of clinical trial data management, statistical programming, and analysis requirements for assembling and presenting trial results to regulatory agencies.
• Strong written communication and presentation skills.

Benefits & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $170,000 - $190,000.