Associate Director – Open-Source Application Development

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Everest Clinical Research

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2004

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Everest Clinical Research est une organisation de recherche sous contrat (CRO) mondiale qui fournit des services complets d'essais cliniques et une expertise en biométrie aux promoteurs pharmaceutiques et biotechnologiques. L'entreprise offre des opérations cliniques et de gestion de projet, une gestion de la qualité basée sur les risques et une surveillance centralisée, une surveillance médicale, une pharmacovigilance, une gestion des données cliniques, de la biostatistique et de la programmation statistique, une stratégie et des soumissions réglementaires, ainsi que des solutions technologiques telles que l'IRT/RTSM et l'ePRO/eCOA. Everest se positionne comme un partenaire de confiance privilégiant la qualité, avec une portée mondiale et une expertise thérapeutique dans les domaines de l'oncologie, de la neurologie, des maladies respiratoires, des maladies rares et de l'immunologie.

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

🎯 Exigences

• 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

🏖️ Avantages

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