Senior Manager, Data Standards

Job Summary

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

Key Responsibilities

• Participate in the development of data and reporting standards for clinical trials
• Ensure compliance with CDISC standards and oversee the creation of necessary documentation for regulatory submissions
• Develop training materials and communicate ongoing standard development activities across the organization

Required Qualifications

• Experience leading the development of standards for data collection, tabulation, analysis, and reporting
• Experience with SDTM is required; CDASH experience is highly recommended
• Familiarity with ADaM and Analysis Results Metadata is helpful
• Active participation in CDISC teams is preferred
• MS with 9 years or BS with 11 years of relevant clinical research experience