Lead Biostatistician

Primary Function of Position:

• As a senior technical leader, set the statistical vision and direction for the design, conduct, and analysis of clinical studies.
• Operate as a fully independent statistical authority, owning multiple business areas and a portfolio of ten or more concurrent projects.
• Represent Intuitive Biostatistics directly with regulatory agencies and the broader scientific community.

Roles & Responsibilities:

• Independently strategize statistical approaches for complex clinical protocols, including Bayesian and frequentist designs.
• Set standards for Statistical Analysis Plans and mock TLFs, and review work from others.
• Manage a portfolio of 10+ projects, set priorities, and allocate statistical effort.

Qualifications:

• Master's or Ph.D. in Biostatistics or Statistics with 9+ years (MS) or 6+ years (PhD) experience.
• Minimum 5 years of clinical trial and medical device experience required.
• Mastery of R, with valued SAS and Python skills, and proven application of AI models to enhance productivity.