Associate Director of SDTM Programming

Job Summary

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

Key Responsibilities

• Provide statistical programming technical support and oversight for outsourced projects, ensuring compliance with regulatory submission standards
• Develop programming standards and templates for datasets and TFLs to enhance efficiency and quality in clinical trial data analysis
• Evaluate and enhance the computing environment system, identifying issues and leading improvements for programming efficiency

Required Qualifications

• Bachelor's Degree in a science or technical field; 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 language and CDISC SDTM/ADaM standards
• Solid understanding of statistical concepts and methodologies in clinical trials
• Knowledge of all phases of drug development and applied statistics