ADaM Standards Engineer

Job Summary

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