Brief Description The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. Responsible for statistical aspects of study design, study analysis/validation, and study documentation. Develop and execute statistical strategy, design, and analyses for clinical trials; oversee work by statistics and programming external vendors. Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. Essential Functions Participate in department and cross‐functional meetings to optimize clinical study designs, endpoints, and analysis strategies. Collaborate with study teams to meet study and recurring report timelines. Support development and implementation of study protocols. Review and provide input to ...