Senior Biostatistician

Primary Function of Position

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.

Roles & Responsibilities

• 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 37 projects simultaneously and take ownership of one specific business or functional area.
• Team Communication: Interpret complex statistical results for cross-functional teams in a clear and actionable manner considering clinical implications and proactively offering alternative solutions.
• 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.
• Mentorship: Provide guidance and leadership to junior biostatisticians.
• Regulatory Compliance: Ensure all activities strictly adhere to Good Clinical Practice (GCP) ISO 14155 and 21 CFR Part 812 regulations.

Qualifications :

Skills Experience Education & Training

• Minimum Degree: Masters (MS) or Ph.D. in Biostatistics or Statistics.
• Professional Experience: Minimum of 6 years of experience with an MS or 3 years with a Ph.D..
• Industry Experience: Minimum of 4 years of experience in clinical trials surgical medical device clinical research strongly preferred.

• Statistical Methods: Proven expertise in advanced and complex statistical methodologies including experience with adaptive designs or Bayesian methods.
• Programming: Mastery of R preferred SAS and Python also considered; ability to write clean functional modular code for a team development environment and train junior team members in best practices.
• Independence & Leadership: Demonstrated ability to work nearly independently while providing functional mentorship to junior biostatisticians.
• External Reputation: Track record of strong professional relationships within the external scientific (biostatistics medical devices clinical trials) and/or regulatory community.

• Communication: Excellent verbal and written communication teamwork and interpersonal skills with both technical and non-technical constituents.

Logistics

• Location: 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.

Additional Information :

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.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

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.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

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 employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time