Associate Director – Open-Source Application Development

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🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $170.000 - $190.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Everest Clinical Research

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2004

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Everest Clinical Research é uma organização de pesquisa por contrato (CRO) global que fornece serviços completos de ensaios clínicos e expertise em biometria para patrocinadores das indústrias farmacêutica e biotecnológica. A empresa oferece operações clínicas e gestão de projetos, gestão de qualidade baseada em risco e monitoramento centralizado, monitoramento médico, farmacovigilância, gestão de dados clínicos, bioestatística e programação estatística, estratégia regulatória e submissões, além de soluções tecnológicas como IRT/RTSM e ePRO/eCOA. A Everest se posiciona como um parceiro de alta qualidade, com alcance global e expertise terapêutica em oncologia, neurologia, doenças respiratórias, doenças raras e imunologia.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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