Senior Principal Statistician

Genentech•Daly City, CA

13d

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 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. The Opportunity: The Statistician is a key member of the cross-functional study or molecule team, responsible for applying statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. This role ensures the scientific rigor and regulatory compliance of the study by contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results. The Statistician plays a critical role in ensuring that each study generates robust, meaningful data to support decision-making and regulatory submissions. You are accountable for strategy and execution of all statistical aspects of a molecule program You ensure the application of digital, design, and data capabilities at the molecule program level You represent PDD on cross-functional teams, such as the Development and Lifecycle Team You ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissions You contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communities You lead statistical design and strategy for the molecule CDP, developing innovative approaches aligned with program objectives You provide specialized expertise and best practices for study design, analysis, and interpretation, guiding cross-functional teams toward high-quality solutions You work independently within broad guidelines to address challenging design or analysis questions, consulting only in the most complex cases You interpret business or regulatory needs and recommend statistical and analytical strategies that optimize study efficiency and regulatory alignment You serve as a technical advisor within the disease area, mentoring statisticians and promoting quality standards and consistency You partner closely with clinical, regulatory, and data science teams to ensure statistical deliverables at the program level are scientifically robust, relevant, clearly communicated, and timely You keep abreast of new developments in drug development through evolving health authority guidance, literature review, conference attendance, and collaborative partnerships You drive the narrative of key results and support responses to health authority interactions You contribute to continuous improvement of statistical processes, templates, and tools within the function You mentor junior staff

Requirements

MSc or PhD in Statistics, Biostatistics, or a related quantitative field
minimum of 12 years of experience in clinical development within the pharmaceutical, biotech, or healthcare sector
proven ability to lead statistical input into clinical development plans and regulatory submissions
strong expertise in applying advanced statistical methods to support data-driven decision-making
proficient in SAS and/or R with deep familiarity with CDISC standards and evolving regulatory data requirements
track record of leading statistical execution and delivering results in a collaborative, team-oriented environment
demonstrated experience with regulatory interactions and filings
strong expertise in clinical trial methodology and statistical principles
familiar with innovative trial designs
capacity for independent thinking and ability to make decisions based upon sound principles
excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
demonstrate respect for cultural differences when interacting with colleagues in the global workplace
excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language
able to effectively partner with stakeholders within and outside of PDD
understand the different subfunctions of PDD and their contributions to drug development

Nice To Haves

Experience working in obesity, diabetes, and cardiovascular disease
Experience working in cross-functional global study teams
Experience with multiple phases of drug development (early and/or late stage)
Experience in mentoring or scientific leadership within a matrix organization
Strategic mindset with the ability to contribute to portfolio-level decisions

Responsibilities

accountable for strategy and execution of all statistical aspects of a molecule program
ensure the application of digital, design, and data capabilities at the molecule program level
represent PDD on cross-functional teams, such as the Development and Lifecycle Team
ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissions
contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communities
lead statistical design and strategy for the molecule CDP, developing innovative approaches aligned with program objectives
provide specialized expertise and best practices for study design, analysis, and interpretation, guiding cross-functional teams toward high-quality solutions
work independently within broad guidelines to address challenging design or analysis questions, consulting only in the most complex cases
interpret business or regulatory needs and recommend statistical and analytical strategies that optimize study efficiency and regulatory alignment
serve as a technical advisor within the disease area, mentoring statisticians and promoting quality standards and consistency
partner closely with clinical, regulatory, and data science teams to ensure statistical deliverables at the program level are scientifically robust, relevant, clearly communicated, and timely
keep abreast of new developments in drug development through evolving health authority guidance, literature review, conference attendance, and collaborative partnerships
drive the narrative of key results and support responses to health authority interactions
contribute to continuous improvement of statistical processes, templates, and tools within the function
mentor junior staff