Senior Data Standards Analyst

Job Summary

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

Key Responsibilities

• Contribute to the development of data and reporting standards for clinical trials, focusing on CDASH and SDTM standards
• Ensure consistency across standard types and educate the organization on their proper use
• Oversee the creation of regulatory submission documentation and consult on conformance issues

Required Qualifications

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