Manager of Data Standards
A company is looking for a Manager, Data Standards. Key Responsibilities Participate in the development of data and reporting standards within assigned therapeutic areas Ensure consistency across standard types and develop training materials for proper use of standards Oversee the creation of SDTM documentation for regulatory submissions and consult on conformance issues Required Qualifications, Training, and Education Experience leading development of standards for data collection, tabulation, analysis, and reporting Experience with SDTM is required; CDASH experience is highly recommended Experience with ADaM and regulatory submission documentation is helpful MS with 8 years or BS with 10 years of relevant clinical research experience Active participation in CDISC teams is preferred
A company is looking for a Manager, Data Standards.
Key Responsibilities
Participate in the development of data and reporting standards within assigned therapeutic areas
Ensure consistency across standard types and develop training materials for proper use of standards
Oversee the creation of SDTM documentation for regulatory submissions and consult on conformance issues
Required Qualifications, Training, and Education
Experience leading development of standards for data collection, tabulation, analysis, and reporting
Experience with SDTM is required; CDASH experience is highly recommended
Experience with ADaM and regulatory submission documentation is helpful
MS with 8 years or BS with 10 years of relevant clinical research experience
Active participation in CDISC teams is preferred
