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

QualificationsRequired 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
Solid 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)

📌 Database Programming Lead Karnataka (India)
🏢 Astellas Pharma
📍 India