Principal Statistician, Biostatistics

Job Summary

A company is looking for a Principal Statistician, Biostatistics.

Key Responsibilities

• Lead the design and reporting of Phase I to IV clinical studies and support regulatory filings
• Develop and execute statistical strategy, design, and analyses for clinical trials
• Collaborate with cross-functional teams and oversee external vendor deliverables

Required Qualifications

• 2 years of experience in the pharmaceutical or biotechnology industry, or a PhD in a related field
• Knowledge of clinical trial design and analysis, including complex statistical methods
• Proficient in SAS and R programming; knowledge of CDISC models and standards preferred
• Familiarity with regulatory requirements and guidelines, such as ICH Guidelines
• Experience with Bayesian and adaptive design preferred