Database Programming Lead

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)