Associate Director, Data Configuration Engineer

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Data Configuration Engineer in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:

Overview: The Associate Director Data Configuration Engineer (DCE) oversees a team that configures and maintains the data pipelines conforming to the common data model, ensuring data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA). The Associate Director DCE provides leadership, supports deliverables, and liaises cross-functionally. This role is crucial to the successful conduct of Takeda’s clinical trials and the delivery of high-quality data in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of Takeda products. Further, CDCS efforts enable valid primary and secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives.

Key Responsibilities:

• Lead the analytics use cases for clinical trials, including study-specific visualizations for data review and analysis, risk-based monitoring analytics use cases, and safety reviews.
• Focus on the analytics space, setting direction and guidance for the team around reporting data models, building reusable analytics libraries, and identifying user-friendly tools and technologies to enable faster configuration for the CDE team.
• Work closely with non-technical users to design analytics, providing recommendations on the best ways to visualize different types of clinical data (e.g., AE, labs) from an end-user standpoint.
• Be an important stakeholder in creating a harmonized structure for visualization purposes, with a good understanding of harmonized data models and data structures, preferably clinical trial-based data models like CDISC.
• Manage and lead teams, ensuring operational success and fostering an inclusive environment.
• Provide guidance in support of broader functional strategy and leadership to junior staff, fostering skill development and professional growth.
• Manage projects, influence organizational goals, maintain frequent communication with peers and customers, and lead teams and projects, serving as a best practice/quality resource.
• Provide mentoring and oversight that facilitates test data transfer and confirms accurate DTA specification.
• Perform tasks to configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR).
• Work with Data Engineers to configure (Extract Transform Load) ETLs and (Extract Load and Transform) ELTs, providing testing and documentation for data pipelines.
• Utilize and contribute to libraries for functions and transformation templates for reuse in study-level configuration tasks.
• Understand FDA requirements and auditing principles, and apply process improvement principles to enhance clinical data configuration processes.
• Partner closely with internal/external stakeholders and data engineers in a collaborative manner.
• Manage timelines, deliverables, and communications across the organization.
• Participate in the development, maintenance, and training rendered by standards and other functions on transfer specs and best practices used by the business.
• Strong project management skills and experience working with cross-functional teams on visual needs.

Qualifications:

• Strong understanding of harmonized data models and data structures, preferably clinical trial-based data models like CDISC.
• Experience in leading analytics use cases for clinical trials, including visualizations, risk-based monitoring, and safety reviews.
• Ability to work closely with non-technical users to design and visualize analytics.
• Proven track record in managing projects, influencing organizational goals, and leading teams.
• Excellent communication skills and the ability to liaise cross-functionally.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelor's degree plus minimum of 8+ years’ experiencein computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.  
• Knowledge of  EDC build, Data Management, Cross functional data review process.
• Knowledge of data flow between clinical data management systems, vendor devices and CDR. 
• Knowledge of XMLS, ALS, APIs and MDR preferred. 
• Experience with one of these languages:  SQL, SAS, R, Python 
• Programming experience in setting up visuals for at least one of the tools is preferred: Jreview, RShiny, Spotfire, Elluminate.
• Understanding of SDTM 
• Understanding of data structures for reporting needs
• Strong working knowledge of clinical trial terminology and data transfer specification expected 
• Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively.  
• Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands.  
• Ability to work independently, take initiative and complete tasks to deadlines.  
• Experience building and designing visual objects, global and TA specific libraries
• Good knowledge of office software (Microsoft Office).  
• Experience with EDC build or data extraction configuration ETL/ELT experience  
• Preferred SAS or R or Python certification
• Preferred experience developing R shiny and Python apps, with Agile development methods, and with Veeva CDB

This position is currently classified as “ Remote” in accordance with Takeda’s Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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