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Associate Director – Open-Source Application Development
Posted 2 months ago
About the role
- Associate Director leading R- and Python-based open-source applications for Everest, a clinical research CRO. Governing compliant automation, CDISC standards, AI-assisted development, and SDLC practices.
Responsibilities
- Define, implement, and govern Everest's open-source application development strategy supporting clinical data standards, statistical programming, and analytics
- Ensure alignment with global regulatory expectations and evolving guidance related to data standards, automation, and advanced analytics
- Oversee the design, development, and maintenance of R- and Python-based applications, packages, and utilities
- Support metadata-driven data models and automation of downstream clinical data activities
- Identify opportunities to streamline workflows, reduce manual effort, and eliminate redundancies through standardized and automated application solutions
- Establish a controlled innovation framework for application development and validation lifecycle
- Define design specifications, coding standards, coding review, version control, change management, and impact assessment practices
- Ensure AI-assisted development aligns with regulatory expectations, data integrity principles, and validation and documentation requirements
- Maintain an SDLC framework for open-source language-based applications, including source control, branching, testing, and release management
- Foster quality, compliance, operational excellence, and innovation in application development
Requirements
- M.Sc., M.A. or higher in Statistics, Computer Science, or a relevant field
- At least 10 years of clinical research and industry experience
- Experience implementing CDISC standards across various therapeutic areas
- Experience supporting regulatory submissions of clinical trial data
- Strong hands-on experience with R, Python, and SAS
- Application development experience, including package/library creation and software design for clinical data and statistical programming use cases
- Experience applying AI and large language model (LLM) tools for coding development, including code generation, code review, testing, and application/tool integration
- Experience with GitHub or similar version control and application development platforms, including code review workflows, branching strategies, and CI/CD practices
- In-depth knowledge of clinical trial data management, statistical programming, and analysis requirements for regulatory trial results
- Strong written communication and presentation skills
- Up to 10% business travel may be required
- Experience developing and delivering training curricula is preferred
Benefits
- Medical, dental, and vision coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- Pension plan
- Generous paid time off and sick leave
- Opportunity to earn a performance based bonus
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