Associate Director – Open-Source Application Development

🕒 August 4

🇺🇸 United States – Remote

💵 $170k - $190k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Lead and provide expertise for Everest's open-source application development strategy supporting clinical data standards, statistical programming, and analytics • Align internally developed tools and applications with global regulatory expectations and evolving guidance related to CDISC data standards, automation, and advanced analytics • Oversee design, development, and maintenance of R- and Python-based applications, packages, and utilities supporting metadata-driven data models and downstream clinical data automation • Identify opportunities to streamline workflows, reduce manual effort, and eliminate redundancies through standardized and automated application solutions • Establish and govern the application development and validation lifecycle, including design specifications, coding standards, code review, version control, change management, and impact assessment • Ensure AI-assisted development approaches meet 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 • Experience with application development, package/library creation, and software design for clinical data and statistical programming use cases • Experience applying AI and large language model (LLM) tools to 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 assembling and presenting trial results to regulatory agencies • Strong written communication and presentation skills • Experience developing and delivering training curricula preferred • Ability to travel for up to 10% business travel

🏖️ 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