J Review (Rave/ Inform)

Job Description

• Programming, specifically Programming, specifically JReview, SQL, R and GitHub. Good to have SAS.
• Create data cleaning reporting solutions study status metrics, and monitoring reports and visualizations required per standard and study specific data review plans.
• Develop a library of reusable checks working closely with data engineers and config specialists.
• Collaborate with cross functional teams in creating business rules and automated check library across TAU.
• Serves as a technical resource for creating data analytics to help with data validation and cleaning.
• Provide programming expertise for data cleaning to efficiently ensure high quality data.
• Ensure accurate delivery by creating macros for Standard listings for the department based on specifications.
• Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests.
• Ability to set up and configure analytics for coding reports, safety reviews and any risk-based monitoring activities.
• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.)
• Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
• Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle),
• EDC build and/or clinical data management experience preferred
• Experience in AWS preferred
• Experience setting up automated validation is preferred
• Knowledge of Database and creating interactive Dashboards are preferred
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)