Data Reviewer Specialist
About the role
Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you. As a Data Reviewer Specialist, you will further our mission by serving as a contributing specialist for studies, independently carrying out data review activities from study execution through report finalization. You will utilize your strong knowledge of regulatory policies and data review requirements to assess scientific data and reporting, support timely audit responses, and ensure the accuracy and integrity of study deliverables. You will work closely with scientific teams and other departments across KCAS, serving as a trusted resource for complex data review activities while maintaining a high level of professional interaction both within and outside of the department. You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.
Responsibilities
- Act as a data reviewer for assigned studies, performing comprehensive review and verification of scientific data with minimal guidance
- Be responsible for final data review and sign-off, including 100% review of Excel spreadsheets, report tables, and manipulated data transmittals
- Verify outliers, repeated samples, positive predose results, placebo results, and other data requiring additional review or investigation
- Review reports and supporting documentation for accuracy, completeness, consistency, and compliance with applicable requirements
- Support