Principal Biostatistician (Biostatistics)

TL;DR

Principal Biostatistician (Biostatistics/Pharma): Designing and analyzing exploratory clinical studies to guide early-phase trial strategy and interpretation with an accent on innovative methodologies and regulatory robustness. Focus on leading the statistical design of adaptive and biomarker-enriched trials and translating emerging data into actionable insights for go/no-go decisions.

Location: South San Francisco, California, USA

Salary: $153,300 - $284,700

Company

hirify.global, a member of the Roche group and pioneer in the biotechnology industry, is dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Lead the statistical design of complex high-priority early-phase studies, including adaptive, platform, and biomarker-enriched trials.
• Champion the use of innovative methodologies, such as Bayesian designs and model-based dose selection.
• Ensure strategic alignment and quality across statistical deliverables to support phase transitions and regulatory interactions.
• Analyze complex high-dimensional data to inform critical early go/no-go decisions.
• Own the statistical content of major regulatory submissions, including INDs and EMA scientific advice packages.
• Collaborate with cross-functional teams across Clinical Development, Pharmacology, and Translational Medicine.

Requirements

• PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field.
• At least 6 years of experience in clinical trial statistics with responsibility for study-level strategy.
• Proven ability to lead statistical input into clinical development plans and regulatory submissions.
• Proficiency in SAS and/or R and deep familiarity with CDISC standards.
• Must be based in South San Francisco, California.

Nice to have

• Experience across multiple drug development phases, with emphasis on Phase I/II trials.
• Familiarity with innovative methods such as MIDD and complex modeling.
• Demonstrated scientific leadership and mentoring within a matrixed organizational structure.
• Strong communication skills for translating complex statistical results to non-technical audiences.

Culture & Benefits

• Equal opportunity employer with a focus on merit, qualifications, and competence.
• Discretionary annual bonus based on individual and company performance.
• Comprehensive benefits package for full-time employees.
• Opportunity to work at a pioneering company with massive investment in R&D.