Associate Director, Clinical Data Engineer; CDE

Position: Associate Director, Clinical Data Engineer (CDE)
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** Job Description*
* ** Clinical Data Engineering (CDE) at Takeda: **  

Key to Takeda's success the Clinical Data Engineering group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis.  CDE also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis.  

** Associate Director, Clinical*
* ** Data Engineer (CDE)*
* Key to Takeda's success is the Clinical Data Engineering team, which provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables.  Under the guidance of Clinical Data Management, the Clinical Data Engineer provides leadership and guidance at the enterprise level for end-to-end data extraction, transformations and construct of data pipelines that conform to the common data model that ensures data ingestion for all clinical data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA) as well other data models that may be required by end users.

Understands and ensures proper data formats for all downstream users for use in the data lake.  Facilitates test data transfer to staging instance and confirms accurate DTA specification. Defines processes and develop and maintain code libraries for use by clinical data configuration specialist to build, maintain, and monitor data pipelines for clinical data and the clinical data repository (CDR) alongside processing specialty data for exploratory analysis.

Develops and maintains library of reusable mapping and transformation functions to be used across studies. CDE contributes to the successful conduct of Takeda's clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of Takeda products. The CDE also monitors end to end performance and KPIs and provides continuous improvement to processes and tools.

Further, CDE efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives.

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* Key Accountabilities:

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* + Ability to manage teams and timelines across multiple functional areas and platforms. Mentor and guide other team members

+ Advanced knowledge and ability to liaise with outside groups in a matrix environment

+ Building required infrastructure for optimal data extraction, transformation and loading of data using cloud technologies like AWS, Azure etc.,

+ Develop end to end processes on the enterprise level for use by the clinical data configuration specialist to prepare data extraction and transformations of raw data quickly and efficiently from various sources at the study level

+ Manage timelines, deliverables and communications across organization

+ Develop and maintain, tools, libraries, and reusable templates of data pipelines and standards for study level consumption by data configuration specialist

+ Collaborate with various vendors and cross functional teams to build and align on data transfer specification and ensure a streamlined process of data integration

+ Develop organizational knowledge of key data sources, systems and be a valuable resource to people in the company on how to best integrate data to pursue company objectives.

+ Provides technical leadership on various aspects of clinical data flow including assisting with the definition, build, and validation of application program interfaces (APIs), data streams, data staging to various systems for data extraction and integration

+ Coordinates with data base builders, clinical data configuration specialists and data management (DM) programmers ensuring accuracy of data integration per…