Senior Biostatistics Lead for Clinical Trials

Intuitive; Sunnyvale (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Intuitive seeks a Lead Biostatistician to define the statistical vision for clinical studies from early feasibility to post-market evidence generation. You will lead design decisions, set standards, and represent statistics with regulatory bodies and external partners.

You will mentor staff, develop SOPs, and drive a data-driven culture across Clinical Affairs, delivering high-impact analyses and insights.

Qualifications

• Experience leading statistical design for complex clinical protocols.
• Ability to influence design decisions across programs and platforms.
• Strong collaboration with regulatory agencies and external partners.

Responsibilities

• Independently strategize statistical approaches for complex protocols, including Bayesian and frequentist designs.
• Set SAPs and mock TLFs, and approve others' works against standards.
• Lead data analysis of trial data ensuring reproducibility and regulatory readiness.
• Manage a portfolio of 10+ projects and allocate statistical effort.
• Shape evidence-generation strategy across surgical specialties and platforms.

Skills

Bayesian design

Frequentist design

SAPs & TLFs

Data analysis

Regulatory engagement

Portfolio management

Mentorship

SOP development

GCP compliance

ISO 14155

Job description

Intuitive seeks a Lead Biostatistician to define the statistical vision for clinical studies from early feasibility to post-market evidence generation. You will lead design decisions, set standards, and represent statistics with regulatory bodies and external partners.

You will mentor staff, develop SOPs, and drive a data-driven culture across Clinical Affairs, delivering high-impact analyses and insights.