Senior Data Standards Analyst

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

Apr 24, 2025 - 20:09

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