Director, Data Standards

Location
Marlborough, MA
Posted
Jul 18, 2018
Discipline
Clinical, Clinical Data
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
  • Provide support across Data Science functional areas to promote and enforce the use of company data standards. Maintain metadata libraries of company standards, as adapted from industry standards, to be used by various functional groups performing data processing. Establish standards governance framework.
  • Review and assess the impact of newly released and updated data standards from SDOs and incorporate into Sunovion’s business practices, as applicable.
  • Review and assess the impact of newly released and updated regulatory agency prescriptions regarding data standards and incorporate into Sunovion’s business practices, as applicable.
  • Promote the development of processes, tools and utilities within Data Science that leverage standardized data in order to increase efficiency of data processing, from data acquisition through data analysis, reporting and submission.
  • Prepare internal SOPs and SWIs related to the use of data standards
  • Communicate Sunovion’s data requirements to external vendors. Interact with external vendor personnel regarding standardized data transfer specifications, as necessary.
  • Interact with SDOs and/or regulatory agencies regarding Sunovion’s data submission requirements and plans.
  • Assist with NDA preparation planning as regards the use of CDISC standards.