Lead Biostatistician, Remote – AI-Driven Trials Leader

Intuitive; Kansas; Remote; USD 150,000 - 230,000; Full time

Job summary

Intuitive seeks a senior Biostatistician (Biostatistician 5) to lead statistical strategy across clinical studies from early feasibility to post-market evidence generation. You will set standards, mentor peers, and partner with regulatory bodies to support device trials and submissions.

You will own complex analyses, direct portfolio activities, and influence cross-functional teams while maintaining high data quality and regulatory compliance.

Qualifications

• Master's or PhD in Biostatistics or Statistics.
• 9+ years with MS or 6+ years with PhD.
• 5+ years of clinical trial experience.
• 5+ years in medical device studies; robotic-assisted devices preferred.
• Strong experience in adaptive designs and Bayesian methods.
• Expertise in external controls, survival and longitudinal modeling.
• Experience with regulatory submissions and GxP environments.
• Proficiency in R; SAS and Python, Git for version control.

Responsibilities

• Design and oversee complex clinical protocols and Bayesian and frequentist designs.
• Develop SAPs, TLFs, and set analysis standards for the portfolio.
• Lead data analyses and interim analyses, ensuring regulatory readiness.
• Manage a portfolio of 10+ concurrent projects with senior stakeholder alignment.
• Shape the Clinical Operations roadmap and evidence generation strategy.
• Communicate statistical concepts clearly to leadership and cross-functional teams.
• Mentor statisticians and oversee external vendors.
• Ensure compliance with GCP, ISO 14155, ICH guidelines and FDA expectations.
• Maintain data structures (SDTM/ADaM) and CDISC standards.

Skills

Biostatistics

Clinical trials

Advanced modeling

AI adoption

Independent leadership

Regulatory engagement

Scientific writing

Communication skills

Education

MS or PhD in Biostatistics/Statistics

Tools

R

SAS

Python

Git

Job description

Intuitive seeks a senior Biostatistician (Biostatistician 5) to lead statistical strategy across clinical studies from early feasibility to post-market evidence generation. You will set standards, mentor peers, and partner with regulatory bodies to support device trials and submissions.

You will own complex analyses, direct portfolio activities, and influence cross-functional teams while maintaining high data quality and regulatory compliance.