The Business Analyst/Project Manager is responsible for leading and managing a portfolio of strategic and transformational enterprise-wide projects that are of varying levels of complexity, size and scope.
Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations.
Draft regulatory documentation from approved sources; review regulatory documentation for consistency and compliance with guidelines; author and review forms supporting information in INDs and Clinical Trial Applications submitted to European Union health authorities.
Performing patch management, software deployments, and network operations for systems and services; administering and maintaining internal (physical), virtual, and cloud-based systems and services to ensure optimum performance and availability.
Serve as the primary interface between Arena and clinical trial sites across all development programs, working closely with Clinical Development and Clinical Operations to ensure the successful execution of high quality clinical studies.
As the lead of transformational projects, you'll interact with all levels of stakeholders across the company and play a critical role in solution delivery as you manage internal and external resources involved in medium to complex projects.