Associate Director – Open-Source Application Development

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

📋 Description

• Provide leadership and expertise in the open-source application development strategy for Everest, focusing on clinical data standards, statistical programming, and analytics.

• Ensure that internally developed tools and applications are aligned with global regulatory standards and adapt to the evolving guidelines related to CDISC data standards, automation, and advanced analytics.

• Supervise the design, development, and maintenance of applications, packages, and utilities in R and Python that support metadata-driven data models and automate clinical data processes.

• Identify and implement opportunities to enhance workflows, minimize manual tasks, and remove redundancies through standardized and automated application solutions.

• Establish and oversee the application development and validation lifecycle, which includes design specifications, coding standards, code reviews, version control, change management, and impact assessments.

• Ensure that AI-assisted development methodologies comply with regulatory expectations, uphold data integrity principles, and meet validation and documentation standards.

• Maintain a Software Development Life Cycle (SDLC) framework for open-source language applications, covering source control, branching, testing, and release management.

• Promote quality, compliance, operational excellence, and innovation throughout the application development process.

⛳️ Requirements

• A Master’s degree (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 industry roles.

• Proven experience in implementing CDISC standards across multiple therapeutic areas.

• Background in supporting regulatory submissions involving clinical trial data.

• Proficient hands-on experience with R, Python, and SAS.

• Experience in application development, package/library creation, and software design tailored for clinical data and statistical programming applications.

• Familiarity with applying AI and large language models (LLMs) to coding development tasks, including code generation, code reviews, testing, and integration of applications/tools.

• Experience utilizing GitHub or similar version control and application development platforms, with a focus on code review workflows, branching strategies, and CI/CD methodologies.

• Comprehensive understanding of clinical trial data management, statistical programming, and analysis requirements for compiling and presenting trial results to regulatory bodies.

• Exceptional written communication and presentation skills.

• Preferably, experience in creating and delivering training curricula.

• Willingness to travel for business, up to 10% of the time.

🏝️ Benefits

• Medical coverage

• Dental coverage

• Vision coverage

• Life and AD&D insurance

• Short-term disability

• Long-term disability

• Tuition reimbursement

• Fitness reimbursement

• Employee assistance program (EAP)

• Pension plan

• Generous paid time off

• Sick leave

• Opportunity to earn a performance-based bonus

• Remote work option

• Up to 10% business travel may be required