Associate Director – Open-Source Application Development

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🔥 4 hours ago

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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

• Define, implement, and govern Everest's open-source application development strategy supporting clinical data standards, statistical programming, and analytics • Align applications 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 automated solutions • Establish and govern application development and validation lifecycle frameworks • Ensure AI-assisted development approaches align with regulatory expectations, data integrity principles, and validation and documentation requirements • Maintain an SDLC framework 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 • Experience applying AI and LLM tools to coding development, code generation, code review, testing, and application integration • Experience with GitHub or similar platforms such as GitLab or Bitbucket • Knowledge of code review workflows, branching strategies, and CI/CD practices • In-depth knowledge of clinical trial data management, statistical programming, and analysis requirements for regulatory submissions • Strong written communication and presentation skills • Training curriculum development and delivery experience preferred • Ability to travel for up to 10% business travel

🏖️ Benefits

• Remote work arrangement • Up to 10% business travel • Accommodations for candidates with disabilities during recruitment and selection upon request