Senior Principal Statistician (Biostatistics)

TL;DR

Senior Principal Statistician (Biostatistics): Leading the statistical design and analysis of exploratory clinical studies to guide early-phase trial strategy and interpretation with an accent on high-dimensional data and regulatory interactions. Focus on implementing Bayesian adaptive trials, model-based decision-making, and shaping early clinical narratives to de-risk development.

Location: South San Francisco, California, USA. Relocation benefits are not available.

Salary: $171,600 - $318,600

Company

hirify.global, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for serious and life-threatening diseases.

What you will do

• Lead statistical design and strategy for complex early-phase studies, including first-in-class and seamless Phase I/II trials.
• Serve as primary statistical advisor for therapeutic area strategies to inform portfolio decisions.
• Address methodological challenges by integrating multimodal data such as biomarkers, imaging, and real-world data.
• Represent the function in senior governance discussions regarding dose optimization and early investment.
• Guide strategic regulatory engagements (e.g., FDA EoP1, EMA Scientific Advice) and author statistical components of submission packages.
• Provide technical leadership and mentorship to statisticians and cross-functional colleagues.

Requirements

• PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 12 years of experience in clinical trial statistics, with advanced contributions to early development strategy.
• Recognized expertise in advanced statistical design (e.g., Bayesian adaptive trials) and model-based decision-making.
• Proven leadership in high-impact cross-functional projects across multiple molecules or disease areas.
• Outstanding communication skills with the ability to influence senior clinical and regulatory stakeholders.
• Location: Must be based in South San Francisco, CA; relocation benefits are not available.

Nice to have

• Experience leading disease area statistical strategy at an enterprise level across Clinical Development and Regulatory teams.
• Familiarity with AI/ML, real-world data, or novel data sources in early-phase analytics.
• Contributions to external working groups, scientific collaborations, or published statistical innovation.

Culture & Benefits

• Comprehensive corporate benefits package.
• Discretionary annual bonus based on individual and company performance.
• Opportunity to work in a pioneering biotech environment focused on solving complex health challenges.
• Employee experience at a company recognized on the Fortune 100 Best Companies to Work For list.