Associate Director, SDTM Programming

Job Summary

A company is looking for an Associate Director - SDTM programming.

Key Responsibilities

• Support project leads on outsourced projects and ensure effective vendor programming implementation for regulatory submissions
• Provide hands-on statistical programming support for regulatory submissions and develop submission data packages
• Develop and maintain programming standards and tools to improve efficiency and quality in clinical trial data analysis

Required Qualifications

• Bachelor's Degree in a science or technical field preferred; Master's Degree preferred
• 10 or more years of experience in the pharmaceutical industry or CROs supporting statistical analysis of clinical trials
• Advanced working knowledge of SAS programming and CDISC SDTM/ADaM implementation
• Understanding of statistical concepts and methods used in clinical trials
• Knowledge of drug development phases and experience with SAS macro/system utility development preferred