Valar Labs is a well funded, fast-growing AI diagnostics startup backed by leading VCs revolutionizing oncology through cutting-edge technology and innovation. We are dedicated to improving patient outcomes through the development and deployment of novel AI-driven diagnostics to reduce treatment uncertainty for oncologists and patients. Our team comprises accomplished researchers, and passionate individuals committed to shaping the future of cancer care.
Valar's Principal Biostatistician will build and lead the biostatistics function, owning statistical strategy across our regulatory submissions and clinical validation programs as we expand across indications and markets.
Responsibilities:
Own study design and Statistical Analysis Plans across the portfolio, including pivotal regulatory submissions: endpoint definition, analysis strategy, prespecification, and governance around database and model lock
Develop analytical and clinical validation strategies for novel biomarker technologies, where established methodology may not directly apply and rigorous approaches must be built rather than borrowed
Serve as the statistical authority in FDA interactions, including Pre-Submissions, information requests, and live defense of analytical choices in agency meetings
Drive prognostic and predictive signature development on our platform representations in partnership with our AI, engineering, and data teams: cohort design, lock strategy, cut-point derivation, discrimination, calibration and independent validation
Help shape how evidence is generated and communicated across publications and clinical strategy, and act as statistical counterpart on collaborations spanning industry, cooperative groups and academia
Required Skills:
Deep expertise in survival analysis, time-to-event methods and biomarker validation
Track record authoring statistical strategy, from study concept through to regulatory and scientific narrative
Rigor in conventional analysis paired with genuine enthusiasm for problems where precedent or data are limited and the approach has to be invented
Ability to explain and defend statistical reasoning to statisticians and non-statisticians alike, including regulators, clinicians and commercial teams
A “doer” mentality: you match the level of process to what the decision actually warrants, and would rather take a defensible position and move than wait for certainty
Hands-on across the full analysis lifecycle in a small team, comfortable moving between deep methodological work and whatever else needs doing that week
(Optional) Familiarity with machine learning model evaluation and digital pathology data
Required Education & Experience:
MS or PhD in biostatistics, statistics or a closely related field
Experience in diagnostics, medical devices or SaMD
(preferred) Experience supporting regulatory submissions and defending analyses to FDA or an equivalent regulator
(preferred) Prognostic or predictive biomarker development in oncology
Previous start-up experience is an asset
The expected base salary range for this role is 180,000-210,000 reflecting a good faith estimate. Actual compensation may vary based on experience, qualifications, and other job-related factors. This role is also eligible for equity and 401(k) with company match.