Associate Director, Data Validation Engineer

About this role

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Job Description:
Objective / Purpose


This Associate Director, Data Validation Engineer (DVE) role will work on Clinical Trial Reporting activities to deliver data listings and visualizations to facilitate the delivery of high-quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. This role partners with Clinical Data Management and works with Takeda study teams to develop listings and visualizations specifications, build and/or oversee implementation of data review objectives/artifacts for clinical trials to support the overall data review plan. In addition, this role will utilize and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEs are responsible for maintaining, testing and documentation of programming tasks and ensuring compliance with trial master file requirements. This role operates in compliance with Takeda SOPs and processes while working closely with Clinical Data Operations Functions and others to enhance existing processes.


Accountabilities

• Provides clinical trial reporting expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies.
• Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
• Partners with Data Configuration Engineer, and Clinical Data Standards teams in the development of standard and study...