Arrowhead Pharmaceuticals is seeking a Data Analyst to support the development and maintenance of the Risk Management Platform and contribute to Good Clinical Practice (GCP) data analytics activities.
Requirements
- Understanding of development platforms and tools involved with data analytics (e.g., ETLs)
- Knowledge in data analytics programming and/or scripting (e.g., Python, SAS)
- Knowledge of Computer System Validation (CSV) and data integrity audits
- Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment)
- Strong knowledge of GCP/GCLP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
Responsibilities
- Support and contribute to risk management analysis efforts associated with GxP functions (primarily GCP)
- Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level
- Identify KPIs involved with risk monitoring from internal and external sources
- Assist and contribute to the development and maintenance of the Risk Management Platform in collaboration with SMEs
- Consume, classify, and integrate external and internal data into the Risk Management Platform
- Assist with platform and tool research associated with the implementation and advancement of the Risk Management Platform
- Train and assist members of the Quality Assurance and Clinical Operations and Development teams on the Risk Management Platform
Other
- Bachelor’s degree in a science discipline is required
- 5 years of relevant experience in a Data Analyst role
- 2 years of relevant experience in GxP function providing Quality and Compliance oversight
- Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA)
- All applicants must have authorization to work in the US for a company
