Senior Data Standards Analyst

Job Summary

A company is looking for a Senior Analyst, Data Standards.

Key Responsibilities

• Contribute to the development of data and reporting standards for clinical trials, focusing on CDASH and SDTM standards
• Participate in cross-functional teams to define standards and ensure consistency across various standard types
• Educate the organization on the use of standards and oversee the creation of relevant documentation for regulatory submissions

Required Qualifications

• Experience leading the development of standards for data collection, tabulation, analysis, and reporting
• Proficiency with SDTM and CDASH standards
• Experience preparing SDTM and/or ADaM datasets for regulatory submissions
• MS with 6 years or BS with 8 years of relevant clinical research experience
• Active participation in CDISC teams is preferred