Associate Director, Data Validation Engineer

About this role

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Job Description
Objective / Purpose:ThisAssociate Director,Data Validation Engineer(DVE)rolewill work on Clinical Trial Reporting activities to deliver data listings and visualizations tofacilitatethe delivery of high-quality datain 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 willutilizeand contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEsare responsible formaintaining, testing and documentation of programming tasks andensuringcompliance with trial master file requirements.This roleoperatesin compliance with Takeda SOPs and processes while workingclosely withClinical Data Operations Functions and others to enhance existing processes.Accountabilities:

• Providesclinical trial reportingexpertiseand leadership in support of global development programs as well as post-marketing registration and non-registration studies.
• Drives strategy with preferred vendors to ensure compliancetoregulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
• Partnerswith Data Configuration Engineer, and Clinical Data Standards teams in the development ofstandard and study specific data cleaning/quality checks, s...