Data have the power to answer more than one question and enable multiple discoveries, but only if Findable, Accessible, Interoperable, and Reusable (FAIR). Making the FAIR way the easy way to manage data requires having the right processes and infrastructure in place from data planning to data release. Adherence to global data standards and terminologies is critical, not only to ensure that data are FAIR but also to ensure data will meet global regulatory expectations (e.g., for FDA submission). The Global Data Standards Manager supports this effort by contributing to the design, implementation and governance of biomedical data standards from protocol development to regulatory submission and beyond, by being a technical, process and business expert on industry-wide biomedical data standards. The Analysis Standards Specialist role requires experience with CDISC ADaM.
Responsibilities and Accountabilities:
Required Technical Qualifications, Experiences and Competencies: