Principal Statistical Programmer - job 2 of 10

Job Summary

A company is looking for a Principal Statistical Programmer, Standards.

Key Responsibilities

• Support the development and maintenance of clinical data standards, including SDTM and ADaM specifications
• Review e-submission packages and provide feedback while ensuring compliance with CDISC and regulatory requirements
• Develop and maintain libraries of CDISC-related metadata and monitor new regulatory requirements related to data standards

Required Qualifications

• Bachelor's degree in computer science, math, statistics, biology, pharmacology, or a related field
• 8+ years of experience as a Statistical Programmer, with recent work on a Global Standards team
• Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements
• Experience in therapeutic areas such as Oncology, Virology, and/or Inflammation is preferred