Clinical Data Sciences (CDS) at Takeda:
Key to Takeda’s success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis.
The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis.
Clinical Data Engineer (CDE), Clinical Data Sciences (CDS):
Key to Takeda’s success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDE leads the integration, design, development, and execution of data pipelines for the ingestion of clinical data from all sources at an enterprise level for use by the clinical data configuration specialist at the study level. The CDE is an enterprise level role and is primarily responsible for ensuring smooth end to end processes for data collection/ingestion from all data collection sources, providing an output into a data lake that is fit for use by downstream end users. The CDE is also responsible for developing and tracking KPIs and other measures across the business and providing continuous improvement for both process and tools. The CDE will also develop and maintain libraries, tools, and reports to increase reuse and overall efficiency for study level roles. The CDE should have a strong understanding of end-to-end clinical data collection and extraction processes as well as strong project management and technical experience. The CDE will be working with cross functional stakeholders to ensure alignment on processes and requirements and often will be required to convert these requirements to technical specifications. The CDE may also need to develop tools and visualizations as part of the continuous improvement process.
Under the guidance of Clinical Data Sciences, 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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