Lead Biostatistician

Lead Biostatistician

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. The Biostatistician 5 operates as a fully independent statistical leader and the recognized go-to statistical authority across Clinical Affairs and beyond, staying abreast of the latest developments in the field and translating them into impactful improvements for the team. 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. This is an individual contributor role carrying substantial technical and strategic leadership expectations without direct people-management responsibility.

Roles & Responsibilities

Study Design & Protocol Development: Independently strategize and develop the statistical approach for complex clinical protocols, including Bayesian and frequentist design selection, endpoint and estimand framing, hypothesis tests, power analyses, sample size justification, randomization design & review, and adaptive and/or interim analysis strategy. Serve as the final internal statistical authority for design decisions across owned studies and advise on design trade-offs at the program and platform level. Serves 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) across the portfolio, defining the standards, templates, and degree of pre-specification for the department. Review and approve SAPs and mock TLFs authored by others against those standards, balancing flexibility and consistency across studies.

Data Analysis: Set the vision and direction for the analysis of clinical trial data, selecting and championing the methodology applied across studies and ensuring analyses are reproducible, defensible, and of a quality that withstands regulatory and peer review. Personally own the most complex or novel analytical problems in the portfolio, and direct interim analyses, database lock, and unblinding activities per study requirements.

Portfolio Management: Manage a portfolio of 10 or more projects simultaneously and take ownership of multiple business or functional areas, setting priorities, sequencing work, and allocating statistical effort across them.

Clinical Operations Roadmap: Serve as the Biostatistics representative and strategic partner in core team and program-level forums, shaping evidence generation strategy across surgical specialties and product platforms, setting execution roadmaps, managing timelines and stakeholder expectations.

Team Communication: Act as an influential voice across Clinical Operations and beyond, with a reputation as the go-to statistician. Influence senior leadership as a key strategic thought partner, distilling statistical complexity into clear, actionable direction with explicit clinical and business implications. 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 with strategic guidance to support regulatory submissions, compliance documents, scientific journals, and medical conferences. Lead additional research as needed to generate clinical evidence, such as analyses of large clinical or administrative databases, systematic literature reviews, and meta-analyses. Stay abreast of the latest developments in biostatistical methodology and translate them into impactful improvements to how the team designs, analyzes, and reports. Independently contribute to the scientific community through peer-reviewed publication, conference presentation, and methodological contribution.

External Engagement: Conduct independent, direct interactions representing Intuitive Biostatistics with regulatory agencies, Principal Investigators (PIs), Key Opinion Leaders (KOLs), and external statisticians, including addressing regulatory authority questions on statistical design and analysis for pre-approval, post-approval, and post-market clinical follow-up studies. 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, consistency, scalability, and traceability. Specify CDISC-aligned data structures (SDTM, ADaM) and establish analysis-ready dataset specifications.

Process Improvement & Departmental Standards: Set the vision for programming and analysis standards across the department, lead by example in own code and deliverables, and implement across the department. Develop and own SOPs and Work Instructions to drive standardization, validation, and quality control of analysis pipelines such that results meet rigorous standards for regulatory submission and scientific publication.

Mentorship & Capability Building: Set the training curriculum for the biostatistics team and deliver training on both biostatistics methodology and programming practice. Provide technical leadership and career-development guidance to statisticians at all junior levels, raising the technical ceiling of the department. Oversee and direct external statistical vendors and CROs.

Regulatory Compliance: Ensure all activities strictly adhere to Good Clinical Practice (GCP), ISO 14155, ICH E9, ICH E6, and 21 CFR Part 812 regulations. Apply situationally relevant FDA guidances including adaptive designs and Bayesian methods for medical device trials.

Qualifications

Skills, Experience, Education, & Training

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; surgical and robotic-assisted device clinical research strongly preferred.

Statistical Methods: Track record of developing and applying industry-leading, innovative, and integrative biostatistical methodology to problems that standard approaches do not solve. Depth expected across several of: adaptive and group-sequential designs, Bayesian methods, use of historical or external controls, survival and longitudinal modeling, hierarchical models, multiplicity control, missing data and sensitivity analysis, and analysis of large real-world datasets.

Programming: Mastery of R required; SAS and Python additionally valued. Demonstrated ability to set programming standards for a team, write clean, functional, modular, well-tested code in a shared development environment, and lead by example in code review and validation practice. Fluent in version control (Git) in a GxP validated environment for reproducible analyses ready for regulatory compliance audits.

AI-Enabled Productivity: Proven experience applying frontier AI models to dramatically expand the productivity of the biostatistician job function as a whole, beyond personal use. Candidates must be able to point to specific, verifiable examples of workflows they have re-engineered with frontier models, and to quantify the resulting gains in cycle time, throughput, or quality. The successful candidate will be expected to drive adoption across the biostatistics team by establishing the patterns, tooling, and human-in-the-loop verification controls that make AI-assisted work reliable, reproducible, and compliant in an international GxP environment.

Independence & Leadership: Fully independent operation with substantial leadership scope, including the ability to set direction for others, resolve ambiguity without escalation, and be held accountable for the technical quality of a multi-project portfolio.

External Reputation: Established reputation and multiple sustained relationships within the external scientific (biostatistics, medical devices, clinical trials) and regulatory community, with a record of independent contribution to that community.

Communication: Excellent verbal and written communication, teamwork, and interpersonal skills with technical and non-technical constituents, including senior leadership and external audiences. Strong scientific writing and editing skills, high attention to detail, and unwavering scientific integrity.

Location: Remote OK. Preference will be given to candidates able to be onsite in Sunnyvale, California or willing to relocate.

Travel: Up to 10%.