Associate Director, Statistical Programming

About the role

This remote leadership role will guide statistical programming activities that support clinical development across phase I-IV studies. The Associate Director will help establish programming standards, oversee deliverables, and partner closely with clinical, biostatistics, and external vendor teams to ensure high-quality analyses and submission-ready outputs. This position is central to maintaining robust data standards and supporting efficient, compliant study execution.

Responsibilities

• Provide strategic input on statistical programming processes and maintain SOPs
• Assist in developing programming standards and tools for clinical project analysis
• Lead projects and oversee contractors to ensure high-quality deliverables
• Program analysis datasets and statistical documents, including ISRs and submissions
• Review and develop CDISC specifications and generate relevant data sets and supporting documents
• Provide statistical programming and validation support for clinical study reports, overseeing vendors as needed
• Develop and review SAPs, case report forms, and other project-specific specifications

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related field; Master's preferred
• Minimum 8 years of clinical research experience, with a focus on SAS programming for phase I-IV trials
• 3-5 years of leadership experience, including at least 3 years as Lead Programmer
• Technical experience with SDTM, ADaM, and Define.XML
• Strong knowledge of SAS functionalities, UNIX, and Windows; R experience is a plus

Benefits

• Comprehensive health, financial, and work-life offerings for employees and their dependents
• Wellness and employee support programs available
• Life insurance and disability coverage provided
• Retirement plans with employer match supported
• Generous paid time off policy