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Takeda Pharmaceutical Company Limited
At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Organization (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Clinical Data 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.
POSITION OBJECTIVES:
Key to Takeda’s success the Clinical Data Management team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Management function 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.
The Clinical Data Engineering (CDE) 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 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.
POSITION ACCOUNTABILITIES:
Experience building data pipelines for various heterogenous data sources.
Identifying, designing, and implementing scalable data delivery pipelines and automating manual processes
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
Coordinate with downstream users such as statistical programmers, SDTM programming, analytics, and clinical data programmers to ensure that outputs meet requirements of end users
Experience creating ELT and ETL to ingest data into data warehouse and data lakes
Experience creating reusable data pipelines for heterogenous data ingestions
Manage and maintain pipelines and troubleshoot data in data lake or warehouse
Provide visualization and analysis of data stored in data lake
Define and track KPIs and provide continuous improvement
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
Provide ad-hoc analysis and visualization as needed
Ensure accurate delivery of data format and data frequency with quality deliverables per specification
Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business.
Collaborate with system architecture team in designing and developing data pipelines as per business needs
Network with key business stakeholders on refining and enhancing the integration of structured and non-structured data.
Provide expertise for structured and non-structured data ingestion
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
Experience in creating data integrity and data quality checks for data ingestion
Coordinates with data base builders, clinical data configuration specialists and data management (DM) programmers ensuring accuracy of data integration per SOPs
Provide technical support / consultancy and end-user support, work with Information Technology (IT) in troubleshooting, reporting, and resolving system issues
Develop and deliver training programs to internal and external team, ensure timely communication of new and/or revised data transfer specs
Continuous Improvement/Continuous Development
Efficiently prepare and process large datasets for various end users for downstream consumption
Understand end to end requirements for stakeholders and contribute to process and conventions for clinical data ingestion and data transfer agreements
Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations
Ensure compliance with own Learning Curricula, corporate and/or GxP requirements
Assists with quality review of above activities performed by a vendor, as needed
Assess and enable clinical data visualization software in the data flows
Performs other duties as assigned within timelines
Performs clinical data engineering tasks according to applicable SOPs (standard operating procedures) and processes.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Educational Qualification:
Bachelor's degree in computer science, data science, biostatistics, mathematics or equivalent experience that provides the skills and knowledge necessary to perform the job.
Experience:
BS with 8+ years’ experience. Minimum of 5 years’ experience in data engineering, building data pipelines to manage heterogenous data ingestions or similar in data integration across multiple sources including collected data.
Experience with Python/R, SQL, NoSQL
Cloud experience (i.e. AWS tools likeEC2, EMR, RDS, Redshift)
Experience with GitLab, GitHub
Experience of data modeling, database design, and data governance.
Experience deploying data pipelines in the cloud
Experience with Apache Spark (databricks)
Experience setting up and working with data warehouse, data lakes (eg: snowflake, Amazon RedShift etc.,)
Experience setting up ELT and ETL
Experience with unstructured data processing and transformation
Experience developing and maintaining data pipelines for large amounts of data efficiently
Must understand database concepts. Knowledge of XML, JSON, APIs.
Demonstrated ability to lead junior Data engineers and 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.
Special Skills/Abilities:
Strong attention to detail, and organizational skills
Strong Project leadership skills
Strong understating of end-to-end processes for data collection, extraction and analysis needs by end users
Strong ability to communicate with cross functional stakeholders
Strong ability to develop technical specifications based on communication from stakeholders
Quick learner and comfortable asking questions, learning new technologies and systems
Good knowledge of office software (Microsoft Office).
Experience creating custom functions Python/R
Strong Cloud computing (AWS, Snowflakes, Databricks)
Ability to visualize large datasets
R shiny/Python App experience a plus
Behavioral Competencies:
Is comfortable with ambiguity.
Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
Supervision:
Supervision required, should be able to function collaboratively (with guidance) with all levels of employees.
License/Certifications:
Preferred to have AWS or Python certification
This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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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.
For Location:
USA - MA - VirtualU.S. Base Salary Range:
108,500.00 - 170,500.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Job Exempt
Yes#LI-Remote
As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.
We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.
Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.
Advance clinical research
Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
Enable end-to-end management of clinical supply
Ensure safety management and inspection readiness
One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.
Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office
It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.
Penny Carlson - Head, Global Clinical Development Operations
The heart of our work
Shining a light on new perspectives
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Integrity
Fairness
Honesty
Perseverance
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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