Senior Statistician, Early Development

This role is in Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across early clinical development at Roche. We partner across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decision-making from first-in-human through proof-of-concept studies.

As trusted partners in early development, we design efficient and innovative clinical trials, apply rigorous statistical methods, and implement high-quality programming and analytical solutions to accelerate timelines, de-risk development, and increase the probability of technical success. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas. Together, we bring scientific rigor, technical innovation, and strategic insight to shape the future of early development and deliver better outcomes for patients.

Early Development Biometrics is also home to Methods Collaboration & Outreach (MCO), which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high-quality Medical Data Review (MDR) and safety signal detection, aligned with Risk-Based Quality Management (RBQM) principles and Critical-to-Quality (CtQ) endpoints.
 

The Opportunity

The Early Development Statistician is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. The Statistician helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with the evolving development strategy.

• You independently lead statistical input into early phase clinical trial designs, ensuring alignment with scientific and translational objectives, for example first in human, dose escalation, proof of concept, or biomarker enriched studies, and you utilize innovative or adaptive methodologies where appropriate

• You own the development and quality review of statistical deliverables including protocols, SAPs, and CRFs, with a focus on fit for purpose design that supports regulatory and internal decision making

• You design and execute complex analyses, often involving PK PD modeling, exploratory biomarker data, or interim futility assessments, and you proactively identify potential data limitations or methodological challenges and implement solutions

• You collaborate with study teams to align study timelines and deliverables, bringing a proactive mindset to evolving scientific priorities

• You interpret and communicate results in context, clearly framing the clinical relevance and implications of early signals to influence go no go decisions, dose or regimen selection, and future trial design

• You lead statistical contributions to CSRs and regulatory documents, for example IND updates and briefing packages, supporting early regulatory interactions and communications with internal governance bodies

Who You Are:

• You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field

• You bring at least 3 years of relevant experience in clinical trial statistics in pharmaceutical, biotech, or CRO settings

• You have demonstrated experience contributing to the design, analysis, and interpretation of clinical studies across different phases

• You have a solid understanding of regulatory expectations and statistical methodologies for clinical development

• You are proficient in SAS and or R and familiar with CDISC standards

• You work autonomously and collaborate effectively in cross functional teams

• You demonstrate independent thinking and make decisions based on sound principles

• You demonstrate excellent strategic agility including problem solving and critical thinking, with agility that extends beyond the technical domain

• You demons