Senior Statistical Programmer

Job Summary

A company is looking for a Senior Statistical Programmer to lead statistical programming efforts in a remote setting.

Key Responsibilities

• Lead the development and validation of high-quality CDISC datasets and author SDTM specifications
• Consult with clients on database design and ensure compliance with data standards and regulatory requirements
• Mentor junior programmers and oversee project scope and budget while communicating progress to management

Required Qualifications

• BA/BS in computer science, statistics, or a related field with at least 5 years of statistical programming experience in the SAS language
• Extensive knowledge of the SDTM model and experience with CDISC standards for data submissions
• Proficiency in SAS/Base programming and experience with clinical trials and regulatory requirements
• Experience with data submission conformance tools and creation of define.xml
• Strong understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines