POSITION SUMMARY:

Provide statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.

• Generate randomization schedules
• Assist with statistical methods review of the clinical study protocol under close supervision of senior biostatistician or above
• Provide and/or verify sample size calculations
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, figure and listing shells
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide programming support and assist with statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assist with statistical consulting tasks under close supervision of senior lead biostatistician or above
• Review output across programs to ensure consistency under close supervision of senior biostatistician
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician under close supervision of senior biostatistician
• Review statistical sections of clinical study reports
• Work directly with sponsors, project managers, and external vendors on statistics-related project components
• Interact directly with study team
• Interact directly with sponsors
• Assist with completion of statistical activities for study within timelines
• Provide units for development of monthly project invoices
• Train and mentor new biostatisticians
• Assist with bid defense meetings
• Other duties as assigned