Senior Biostatistician: Visionary, Remote Clinical Analytics

Socket.dev; Sunnyvale (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Intuitive Surgical seeks a Lead Biostatistician to define statistical strategy across early feasibility to post-market studies. You will set standards, train teams, and act as the go-to statistician for regulatory submissions and external stakeholders.

The role involves independent leadership without direct reports, oversight of 10+ concurrent projects, and collaboration across Clinical Affairs and external partners. Remote OK with preference for Sunnyvale onsite.

Qualifications

• Master's (MS) or Ph.D. in Biostatistics or Statistics.
• Minimum of 9 years with MS, or 6 years with PhD.
• Minimum of 5 years of clinical trial experience.
• Minimum of 5 years of medical device experience.
• Track record of innovative biostatistical methods across projects.

Responsibilities

• Independently strategize statistical approaches for complex protocols.
• Set SAPs and mock TLFs standards and templates.
• Own analyses for the most complex problems and direct interim analyses.
• Manage a portfolio of 10+ projects across functional areas.
• Represent statistics with regulatory agencies and external leaders.

Skills

Biostatistics leadership

Regulatory submissions

SAS

R

Python

Education

MS in Biostatistics

PhD in Biostatistics

Tools

R

SAS

Python

Job description

Intuitive Surgical seeks a Lead Biostatistician to define statistical strategy across early feasibility to post-market studies. You will set standards, train teams, and act as the go-to statistician for regulatory submissions and external stakeholders.

The role involves independent leadership without direct reports, oversight of 10+ concurrent projects, and collaboration across Clinical Affairs and external partners. Remote OK with preference for Sunnyvale onsite.