Associate Director, Open-Source Application Development

• 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.
• 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 R- and Python-based applications, packages, and utilities that support metadata-driven data models for automation of downstream clinical data activities.
• Identify opportunities to streamline workflows, reduce manual effort, and eliminate redundancies through custom-built, standardized, and automated application solutions.
• 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.
• Foster a culture that balances quality, compliance, and operational excellence with thoughtful innovation in application development.

• 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 SAS, 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 CI/CD practices.
• 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.
• Travel level specification: this position may require up to 10% business travel.

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario Canada and US headquarters in New Jersey USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.