Principal Statistician, Biostatistics
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