Biostatistician (Translational and Exploratory Biostatistics)

Roche • South San Francisco, CA

5d • $120,800 - $224,400 • Onsite

About The Position

This role is within Biostatistics, a core function within Product Development Data Science and Analytics (PDD) that provides strategic leadership and scientific rigor across Development at Roche. Biostatistics identifies opportunities to apply the full breadth of data, digital, and design capabilities to deploy innovative methods across PDD, PD and the broader Roche Pharma organization. As trusted analytical partners in end-to-end drug development, Biostatistics leverages data to drive scientifically rigorous programmatic decisions across Roche’s Development portfolio; Biostatistics designs robust trials and analysis plans that increase the probability of technical success, accelerating timelines to advance Roche’s clinical pipeline and promote regulatory success — ultimately bringing medicines to our patients faster. This position is based in South San Francisco, on site. The Biostatistician will work across diverse therapeutic areas including Ophthalmology, Cardiovascular, Renal, and Metabolism (CVRM), and Immunology portfolios, contributing to projects at the intersection of statistics, data science, and clinical development. In this dynamic role, you will balance support for core clinical trial operations with translational research. You will assist in providing statistical input and hands-on execution for both traditional studies and complex exploratory initiatives, utilizing multimodal data – including biomarkers, imaging, and digital health measurements – to advance high-value work and inform molecule-level development decisions. As a statistical partner within cross-functional teams, you will help ensure scientific rigor and analytical excellence. You will support the analysis of diverse and complex datasets, apply established methodologies, and help build the evidence required to support strategic decision-making and global regulatory submissions.

Requirements

• Hold a PhD or MSc in Statistics, Biostatistics, Machine Learning, or a closely related quantitative discipline.
• 0-2 years of relevant experience in clinical trial statistics or applied data science within a pharmaceutical, biotech, or CRO setting.
• Possess an understanding of statistical principles and methodology relevant to the analysis of multimodal data to drive data-informed decision-making.
• Proficient in programming using R, Python, and/or SAS to solve analytical problems.
• Demonstrate capacity for independent thinking and the ability to make decisions based upon sound principles.
• Excellent verbal and written communication skills, with the ability to summarize findings clearly and explain technical concepts to diverse stakeholders with support from senior colleagues.
• Thrive in a global environment, demonstrating respect for cultural differences and the ability to work effectively within a matrixed team structure.

Nice To Haves

• Experience in at least one specialized data domain: biomarkers, imaging, or digital health measurements.
• Experience or academic background in translational and exploratory analyses.
• Familiarity or academic knowledge of operating as a study-level statistician, including regulatory guidelines (e.g., ICH), CDISC standards, and standard clinical trial deliverables.
• Knowledge of multiple drug development phases (early and late stage), clinical trial design, and an understanding of the broader pharmaceutical industry context.
• Experience working in cross-functional or scientific project teams.

Responsibilities

• Contribute to the statistical execution and analytical strategy for a diverse portfolio of work, ranging from clinical study deliverables to translational and exploratory initiatives under guidance, ensuring scientific integrity across all deliverables.
• Perform or support hands-on analysis of multimodal data, researching and applying statistical methodologies and predictive modeling to address clinical challenges, escalating issues when needed.
• Support statistical execution for traditional clinical trials under guidance, which includes assisting with study design, protocol development, drafting Statistical Analysis Plans (SAPs), and supporting Clinical Study Reports (CSRs) for regulatory submissions.
• Participate as a statistical team member on cross-functional teams, helping to translate complex data into clear communications and actionable insights with support from senior colleagues.
• Represent Biostatistics and PDD on cross-functional project teams, ensuring the statistical rigor of study deliverables under guidance.
• Maintain up-to-date knowledge of the latest developments within the fields of statistics, machine learning, and data science to ensure the application of appropriate analytical approaches.
• Apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations.
• Adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological expertise.

Benefits

• Discretionary annual bonus may be available based on individual and Company performance.
• Qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level