Principal Biostatistician

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 include generating randomization schedules, developing statistical methods for clinical study protocols, providing sample size calculations, contributing to case report form development, and authoring statistical analysis plans. The role involves generating analysis datasets, tables, figures, and listings using SAS, performing quality control, and providing statistical support for regulatory requests. The position also involves serving as a biostatistical consultant, reviewing statistical sections of clinical study reports, working directly with sponsors and project managers, leading statistical activities, and assisting with budget development.