[Hiring] Lead Biostatistician @Intuitive

Role Description

As a senior technical leader within the Clinical Affairs department, the Lead Biostatistician (Biostatistician 5) sets the statistical vision and direction for the design, conduct, and analysis of clinical studies spanning early feasibility through pivotal pre-market trials and post-market evidence generation. This role owns multiple business or functional areas and a portfolio of ten or more concurrent projects, sets the programming and analysis standards the department works to, develops the training curricula, SOPs, and work instructions that build capability across all levels of the function, and represents Intuitive Biostatistics directly with regulatory agencies, principal investigators, key opinion leaders, and the broader scientific community.

Roles & Responsibilities

• Study Design & Protocol Development:
  • Independently strategize and develop the statistical approach for complex clinical protocols.
  • Serve as the final internal statistical authority for design decisions across owned studies.
  • Serve Data Monitoring Committees (DMCs, DSMBs) as the unblinded sponsor statistician.
• Statistical Analysis Plans & Mock TLFs:
  • Set the vision and direction for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs).
  • Review and approve SAPs and mock TLFs authored by others.
• Data Analysis:
  • Set the vision and direction for the analysis of clinical trial data.
  • Personally own the most complex or novel analytical problems in the portfolio.
• Portfolio Management:
  • Manage a portfolio of 10 or more projects simultaneously.
  • Set priorities, sequencing work, and allocating statistical effort across projects.
• Clinical Operations Roadmap:
  • Serve as the Biostatistics representative and strategic partner in core team and program-level forums.
• Team Communication:
  • Act as an influential voice across Clinical Operations and beyond.
  • Lead meetings and set agendas for the biostatistics team.
• Scientific Literature & Evidence Generation:
  • Write or edit the methods, results, and interpretation sections for a portfolio of studies.
  • Independently contribute to the scientific community through peer-reviewed publication.
• External Engagement:
  • Conduct independent, direct interactions representing Intuitive Biostatistics with regulatory agencies.
  • Sustain multiple external relationships and be regarded as a thought leader in the field.
• Data Management Support:
  • Co-strategize with Data Management to develop the direction for data quality.
• Process Improvement & Departmental Standards:
  • Set the vision for programming and analysis standards across the department.
  • Develop and own SOPs and Work Instructions to drive standardization.
• Mentorship & Capability Building:
  • Set the training curriculum for the biostatistics team and deliver training.
  • Provide technical leadership and career-development guidance to statisticians.
• Regulatory Compliance:
  • Ensure all activities strictly adhere to Good Clinical Practice (GCP) and other regulations.

Qualifications

• Minimum Degree: Master's (MS) or Ph.D. in Biostatistics or Statistics.
• Professional Experience: Minimum of 9 years of experience with an MS, or 6 years with a Ph.D.
• Clinical Trial Experience: Minimum of 5 years of clinical trial experience required.
• Medical Device Experience: Minimum of 5 years of medical device experience required.
• Statistical Methods: Track record of developing and applying innovative biostatistical methodology.
• Programming: Mastery of R required; SAS and Python additionally valued.
• AI-Enabled Productivity: Proven experience applying frontier AI models to expand productivity.
• Independence & Leadership: Fully independent operation with substantial leadership scope.
• External Reputation: Established reputation and relationships within the external scientific community.
• Communication: Excellent verbal and written communication skills.

Logistics

• Location: Remote OK. Preference for candidates able to be onsite in Sunnyvale, California.
• Travel: Up to 10%.

Additional Information

• Due to the nature of our business, proof of vaccination against certain diseases may be required.
• Intuitive is an Equal Opportunity Employer.
• We will consider for employment qualified applicants with arrest and conviction records.