Associate Director of Statistical Programming

Job Summary

To support clinical development and regulatory filing, the remote Associate Director of Statistical Programming will provide statistical programming support for compounds at various stages, serving as the study lead programmer for assigned clinical trials and collaborating with study teams to ensure high-quality deliverables.

Key responsibilities:

• Serve as the study lead programmer for assigned clinical trials, collaborating with statisticians and data management teams
• Review and ensure the quality of Define packages and integrated datasets to meet CDISC standards and regulatory requirements
• Perform statistical analyses and independent validation of vendor deliverables and internal outputs

Required qualifications:

• Master's Degree in Biostatistics, Statistics, Computer Science, or a related field with at least 12 years of experience in statistical programming for clinical trials
• Deep understanding of data standards and experience with Pinnacle 21 validation reports and Define XML packages
• Proficiency in statistical software such as SAS, including advanced data steps and macro languages
• Strong organizational and project management skills with a proven ability to work on multiple projects in a fast-paced environment
• Excellent interpersonal skills and a collaborative mindset, capable of effective communication in a remote work setting