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 contribute to early phase trial design under guidance, leveraging standard and adaptive methods for small samples and exploratory objectives, for example dose escalation models and Bayesian approaches

• You draft and review protocols, SAPs, and CRFs using established templates and examples, ensuring alignment with early development goals such as pharmacokinetics, pharmacodynamics, and early efficacy signals

• You perform or support statistical analyses per SAPs, often with non traditional endpoints or biomarkers, and proactively flag data anomalies or design related challenges given smaller datasets and less mature endpoints

• You collaborate with study teams to meet deliverables on accelerated timelines, adhering to evolving processes common in early phase trials

• You summarize findings clearly with support, translating complex outputs into concise insights that inform early go no go decisions or subsequent phase designs

• You contribute to clinical study reports and regulatory submissions, supporting documentation for INDs, EMA scientific advice, and FDA pre IND meetings, using appropriate templates

• You apply judgment to solve moderately complex statistical or data issues, balancing rigor with the flexibility needed in early phase development, and seek guidance when facing novel or ambiguous situations

• You adhere to functional standards and participate in peer review and mentoring to uphold quality while building expertise in early phase methodology and regulatory expectations

• You work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding

Who You Are:

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

• You bring 0 to 2+ years of relevant experience in clinical trial statistics in pharmaceutical, biotech, or CRO settings

• You are familiar with ICH guidelines, GCP, and regulatory requirements such as FDA and EMA

• You have a strong understanding of statistical principles and methodologies relevant to clinical trial design and analysis

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

• 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 demonstrate respect for cultural differences when interacting with colleagues in the global workplace

• You have excellent verbal and written communication skills in presentation and writing, with the ability to explain complex technical concepts in clear language

Preferred:

• Experience working in cross-functional global study teams, including Clinical Pharmacology, Translational Medicine, and Early Clinical Development

• Effective communication skills with the ability to translate complex, often exploratory or model-based statistical concepts for non-statistical audiences, including clinicians and early decision-makers

• Basic understanding of the multiple phases of drug development, with a strong emphasis on early-phase (Phase I/II) design and analysis, including first-in-human, SAD/MAD, and proof-of-concept studies

• Experience within a matrixed early development environment, including providing statistical guidance in fast-paced, high-uncertainty settings

• Familiarity with innovative design methods (e.g., Bayesian designs, model-informed drug development) and regulatory expectations for exploratory endpoints

• Agility and comfort working with incomplete or evolving data and pivoting approaches based on emerging results in early clinical trials

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $120,800 - $224,400.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below. 

Benefits

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