Associate Director – Open-Source Application Development

This is a fully remote position, open to applicants in Canada.

📋 Description

• Develop, implement, and manage Everest's strategy for open-source application development that supports clinical data standards, statistical programming, and analytics.

• Ensure compliance with global regulatory standards and adapt to evolving guidelines concerning data standards, automation, and advanced analytics.

• Supervise the design, development, and upkeep of applications, packages, and utilities built with R and Python.

• Facilitate metadata-driven data modeling and automate downstream clinical data processes.

• Identify ways to enhance workflows, minimize manual tasks, and eliminate redundancies through standardized and automated application solutions.

• Create a controlled innovation framework for the lifecycle of application development and validation.

• Establish design specifications, coding standards, coding review procedures, version control, change management, and impact assessment methodologies.

• Ensure that AI-assisted development meets regulatory standards, data integrity principles, as well as validation and documentation requirements.

• Maintain a software development lifecycle (SDLC) framework for applications based on open-source languages, incorporating source control, branching, testing, and release management.

• Promote quality, compliance, operational excellence, and innovation in application development.

⛳️ Requirements

• M.Sc., M.A. or higher in Statistics, Computer Science, or a related discipline.

• A minimum of 10 years of experience in clinical research and the industry.

• Proven experience in implementing CDISC standards across various therapeutic domains.

• Experience in supporting regulatory submissions of clinical trial data.

• Strong hands-on proficiency with R, Python, and SAS.

• Background in application development, including the creation of packages/libraries and software design for clinical data and statistical programming applications.

• Experience utilizing AI and large language model (LLM) tools for coding development, including aspects such as code generation, code review, testing, and integration of applications/tools.

• Familiarity with GitHub or similar version control and application development platforms, incorporating code review workflows, branching strategies, and CI/CD practices.

• Comprehensive knowledge of clinical trial data management, statistical programming, and analysis needs for regulatory trial results.

• Excellent written communication and presentation abilities.

• Willingness to travel for business up to 10% may be necessary.

• Experience in developing and delivering training curricula is preferred.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Life and AD&D insurance.

• Short-term and long-term disability coverage.

• Tuition reimbursement program.

• Fitness reimbursement benefits.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.