Senior Biostatistician - Clinical Trials

It started with a simple idea: what if surgery could be less invasive and recovery less painful? As a global leader in robotic-assisted surgery and minimally invasive care , our technologies-like the da Vinci surgical system and Ion -have transformed how care is delivered for millions of patients worldwide.
We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
If you're ready to contribute to something bigger than yourself and help transform the future of healthcare , you'll find your purpose here.
As a key member of the Clinical Affairs department, the Senior Biostatistician (Biostatistician IV) provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early pre-market to post-market evidence generation. The Biostatistician IV is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure timely and high quality delivery of results. This role serves as a nearly independent statistical lead, providing technical leadership by improving analysis processes, mentoring junior staff, and managing a diverse project portfolio to ensure that clinical evidence meets the highest standards for regulatory submissions and scientific publication.
Study Design & Protocol Development: Lead the writing of statistical sections for complex clinical protocols with limited supervision, ensuring robust study designs, hypothesis tests, power analyses, and sample size justifications.
Data Analysis: Utilize appropriate and robust statistical and programming methodology in the analysis of clinical trial data, including complex and advanced methods as needed, ensuring high-quality results for regulatory submissions and scientific publications.
Clinical Operations Roadmap: Serve as the Biostatistics representative in core team meetings, setting functional roadmaps and managing stakeholder expectations.
Portfolio Management: Manage a portfolio of 3-7 projects simultaneously and take ownership of one specific business or functional area.
Scientific Literature and Evidence Generation: Independently search and learn from scientific literature. Write complete methods, results, and analysis interpretation sections with supervision for regulatory submissions, compliance, scientific journals, and medical conferences. Explore novel biostatistical & programming methodology applications.
External Engagement: Engage with external stakeholders, including regulatory agencies, Principal Investigators (PIs), and Key Opinion Leaders (KOLs) to define requirements, generate deliverables, and gather feedback.
Data Management Support: Partner with Data Management to co-standardize edit specifications, critical variable lists, data structures, and extraction workflows to ensure data integrity and scalability.

Process Improvement: Improve standardization and quality control of analysis pipelines across projects, ensuring high-quality results for regulatory submissions and scientific publications. Improve and implement SOPs and WIs for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs), balancing flexibility and consistency across studies.
Regulatory Compliance: Ensure all activities strictly adhere to Good Clinical Practice (GCP), ISO 14155, and 21 CFR Part 812 regulations.
Skills, Experience, Education, & Training
D. in Biostatistics or Statistics.
Industry Experience: Minimum of 4 years of experience in clinical trials, surgical medical device clinical research strongly preferred.

Programming: Mastery of R preferred, SAS and Python also considered; Track record of strong professional relationships within the external scientific (biostatistics, medical devices, clinical trials) and/or regulatory community.

• Preference will be given to candidates able to be onsite in Sunnyvale, California or willing to relocate.
• Travel: Position may require up to 10% travel.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee'sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. The target compensation ranges are listed.