Principal Biostatistician

Position Summary

Job Description

Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.

Essential functions of the job include but are not limited to:

• Generate and/or verify randomization schedules
• Develop and review statistical methods of the clinical study protocol including complex study designs
• Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase
• Review statistical analysis plans written by other biostatisticians
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Ability to serve as a biostatistical consul