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:

Key to Takeda’s success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer.  Work with Data Engineer to configure (Extract Transform Load) ETLs and (Extract Load and Transform) ELTs. Provide testing and documentation for data pipelines. Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. 

The Associate Director Data Configuration Engineer (DCE) oversees a team that configures and maintains the data pipelines that conform to the common data model that ensures 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. Provides mentoring and oversight that facilitates test data transfer and confirms accurate DTA specification. Performs tasks to configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR). DCE 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. Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives.  

Responsibilities include managing projects, influencing organizational goals, maintaining frequent communication with peers and customers, and leading teams and projects, serving as a best practice/quality resource.

ACCOUNTABILITIES:

• Ability to manage teams and timelines across multiple functional areas and platforms
• Thorough understanding of industry standards and ways of working
• Understand FDA requirements and understanding of auditing principles
• Manage and lead teams, ensuring operational success and fostering an inclusive environment
• Provide guidance in support of broader functional strategy
• Provide leadership and mentoring to junior staff, fostering skill development and professional growth
• Understanding of transformations and visualization of data
• Partner closely with internal/external stakeholders and data engineers in a collaborative manner 
• Manage timelines, deliverables and communications across organization
• Strong project management skills
• Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business 
• Apply process improvement principles to enhance clinical data configuration processes
• Experience working with cross-functional teams on visual needs

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.  
• Experience with EDC build, Data Management, and EDC extraction configuration  
• 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 
• Understanding of SDTM 
• 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
• Programming experience in JReview or any other visualization tool used for Clinical trials
• 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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