Principal Biostatistician

Provides statistical support for all phases of clinical development. 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. Key functions involve generating randomization schedules, developing statistical methods, providing sample size calculations, and contributing to case report forms. Additional tasks include authoring statistical analysis plans, reviewing plans written by others, generating analysis datasets, and performing quality control for SAS programs and study documents. The role also involves serving as a biostatistical consultant, reviewing output for consistency, providing statistical analysis to Data Monitoring Committees, and working directly with sponsors and project managers. Furthermore, this role participates in budget development, departmental procedures, and ensures studies align with agreed budgets.