Principal Biostatistician - Remote

Overview

The Principal Biostatistician provides statistical support for all phases of clinical development, including writing and reviewing protocols, statistical analysis plans, and conducting statistical analyses.

In Short

• Generate and verify randomization schedules.
• Develop and review statistical methods for clinical study protocols.
• Provide sample size calculations and perform advanced calculations.
• Author and review statistical analysis plans.
• Generate analysis datasets, tables, figures, and listings using SAS.
• Perform quality control for statistical programs and documents.
• Consult on statistical activities for regulatory agencies.
• Lead statistical activities within project timelines.
• Assist with budget development and review project invoices.
• Participate in developing departmental procedures and standards.

Requirements

• Master's degree in Statistics or related field with 10+ years experience; or PhD with 7+ years experience.
• Experience with SAS.
• Knowledge of industry standards (ICH guidelines, CDISC, FDA guidelines).
• Broad knowledge of advanced statistical concepts.

Benefits

• Work in a collaborative environment.
• Opportunity for professional growth.
• Engage in meaningful work in clinical trials.
• Flexible working arrangements.