Senior Statistician, Early Development

About the role

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.

Responsibilities

• Contribute to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions.
• Lead statistical input into early phase clinical trial designs, ensuring alignment with scientific and translational objectives.
• 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.
• Design and execute complex analyses, often involving PK PD modeling, exploratory biomarker data, or interim futility assessments, and proactively identify potential data limitations or methodological challenges and implement solutions.
• Collaborate with study teams to align study timelines and deliverables, bringing a proactive mindset to evolving scientific priorities.
• 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.
• 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.

Qualifications

• MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.
• At least 3 years of relevant experience in clinical trial statistics in pharmaceutical, biotech, or CRO settings.
• Demonstrated experience contributing to the design, analysis, and interpretation of clinical studies across different phases.
• Solid understanding of regulatory expectations and statistical methodologies for clinical development.
• Proficient in SAS and/or R and familiar with CDISC standards.

Skills

• Autonomous work and effective collaboration in cross-functional teams.
• Independent thinking and decision-making based on sound principles.
• Excellent strategic agility, including problem-solving and critical thinking, with agility that extends beyond the technical domain.
• Respect for cultural differences when interacting with colleagues in the global workplace.
• Excellent verbal and written communication skills in presentation and writing, with the ability to explain complex technical concepts in clear language.

Benefits

This position qualifies for benefits, and a discretionary annual bonus may be available based on individual and Company performance. The expected salary range for this position based on the primary location of California is $136,900 - $254,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.