Highlights
Purpose and Scope: The Clinical Data Enablement (CDE) Database Build Lead will perform the creation and maintenance of clinical databases for Phase I-IV clinical trials executed by Astellas. Preferred Qualifications: Technical competency with programming languages (i.e. R, Python, SAS, SQL, etc…) used to support clinical trial data flows, reporting, analysis and/or data sharing.
Numbers & Facts
| Location | Northbrook, IL |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 2,500 to 4,999 employees |
| Website | https://www.astellas.com/us/ |
Description
Purpose and Scope:
The Clinical Data Enablement (CDE) Database Build Lead will perform the creation and maintenance of clinical databases for Phase I-IV clinical trials executed by Astellas. An example of a clinical database would include an electronic data collection system (EDC) but could also include other data collection or review systems as appropriate.
Responsibilities and Accountabilities:
- Performs initial clinical database builds and associated updates per agreed upon requirements and established timelines
- Contributes to related technical and/or process improvement initiatives associated with database builds and related efforts
- Collaborates with any vendors providing programming support for clinical database development, as appropriate
- Collaborates cross functionally to address any issues with the delivery or quality of supported clinical databases
Required Qualifications:
- BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline
- Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives
- Prior experience in clinical database programming or related role
- Strong verbal and written communication skills
- Demonstrated experience collaborating with others to achieve an objective
- Familiarity with all phases of clinical development
Preferred Qualifications:
- Technical competency with programming languages (i.e. R, Python, SAS, SQL, etc…) used to support clinical trial data flows, reporting, analysis and/or data sharing
- Demonstrated ability and experience contributing to global process or system improvement projects
- Knowledge of data standards in industry (CDISC, CDASH)
About Company
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.