Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters. Clinical Data Sciences (CD S ) at Takeda:
Key to Takeda's success the Clinical Data Sciences team provid es 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 (CD E) , Clinical Data Sciences (CDS) :
Key to Takeda's success is the Clinical Data Engineering team , provid es strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDE leads the integration of collected data from all sources , along with completion of clinical trial data deliverables from study start-up through database lock and beyond.
Under the guidance of Clinical Data Sciences, the C linical D ata E ngineer architects and maintains the construct of 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, e PRO, e COA ) . Coordinate s cross functionally, facilitate s test data transfer and confirms accurate DTA specification. Performs tasks to b uild, maintain, and monitor data flow integration between collected data and the clinical data repository ( CDR ) alongside processing specialty data for exploratory analysis. 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. Further, CDE efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and achieve company objectives. Key Accountabilities:
- P erforms clinical data engineering tasks according to applicable SOPs (standard operating procedures) and processes .
- Drive External data transfer in an individual contributor role that requires data engineering leadership for clinical data collection across multiple data sources and the ability to partner closely with internal/external stakeholders in a collaborative manner.
- Collaborate with various vendors and cross functional teams to build and align on data transfer specification and ensure a streamlined process of data integration .
- Ensure accurate delivery of data format and data frequency with quality deliverables per specification .
- Participate in the development , maintenance and training rendered by standard s and other functions on transfer specs and best practices used by business.
- Network with key business stakeholders on refining and enhancing the integration of structured and non-structured data .
- 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 ) to various systems for data extraction and integration .
- Coordinates with data base builders and data management ( DM ) programmers ensuring accuracy of data integration per SOPs.
- Provide basic 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.
- Assists with quality review of above activities performed by a vendor , as needed.
- Assess and enable clinical data visualization software in the data flows
- Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations .
- Ensure compliance with own Learning Curricula, corporate and/or G x P requirements.
- Performs other duties as assigned within timelines
- Bachelor's degree in 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.
Special Skills/Abilities :
- MS with 8+ years experience or BS with 10+ years experience . Minimum of 5 years' experience in clinical data engineering or similar in data integration across multiple sources including collected data and CDR alongside processing specialty data for exploratory analysis .
- Knowledge of data flow between clinical data management system s, vendor devices and CDR .
- Must understand database concepts. Knowledge of XML, ALS , APIs and MDR preferred.
- Strong working knowledge of clinical trial terminology and data transfer s pecification expected .
- Proven ability to manage and communicate effectively with service providers including Budgeting, forecasting, negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
- 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. Strong knowledge of MS Word, Excel, PowerPoint, Access, and Outlook .
- Ability to work independently, take initiative and complete tasks to deadlines.
Behavioral Competencies :
- Strong attention to detail, and organizational skills
- Good time management skills
- Quick learner and comfortable asking questions, learning new technologies and systems
- Good knowledge of office software (Microsoft Office).
Job Complexity :
- Is comfortable with ambiguity.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Medium - High complexity project.
- Occasional domestic/international travel to other Takeda sites, strategic partners, and therapeutic area events may be required.
- Supervision required, should be able to function collaboratively (with guidance) with all levels of employees.
Physical Demands :
- Preferred to have SAS or R or Python c ertification ,
Travel Requirements :
- Ability to sit and stand for long periods of time .
- Carrying, handling, and reaching for objects.
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
- Requires approximately 1-2 domestic trips annually and up to 1 international trip .
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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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..... click apply for full job details