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ADaM Standards Engineer
A company is looking for an ADaM Standards Engineer, FSP. Key Responsibilities Develop, update, and maintain ADaM standards Review SDTM standards for updates and impacts on current ADaM CORE standards Participate in study specific ADaM submission package reviews across multiple authorities Required Qualifications Bachelor's degree in computer science, math, statistics, biology, pharmacology, or related field 8+ years' experience as a Statistical Programmer with recent experience on a Global Standards team Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements Therapeutic experience in Oncology, Virology, and/or Inflammation is preferred
A company is looking for an ADaM Standards Engineer, FSP.
Key Responsibilities
Develop, update, and maintain ADaM standards
Review SDTM standards for updates and impacts on current ADaM CORE standards
Participate in study specific ADaM submission package reviews across multiple authorities
Required Qualifications
Bachelor's degree in computer science, math, statistics, biology, pharmacology, or related field
8+ years' experience as a Statistical Programmer with recent experience on a Global Standards team
Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements
Therapeutic experience in Oncology, Virology, and/or Inflammation is preferred
