Principal Biostatistician

Senior Principal StatisticianA 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 programYou ensure the application of digital, design, and data capabilities at the molecule program levelYou represent PDD on cross-functional teams, such as the Development and Lifecycle TeamYou ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissionsYou contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communitiesYou lead statistical design and strategy for the molecule CDP, developing innovative approaches aligned with program objectivesYou provide specialized expertise and best practices for study design, analysis, and interpretation, guiding cross-functional teams toward high-quality solutionsYou work independently within broad guidelines to address challenging design or analysis questions, consulting only in the most complex casesYou interpret business or regulatory needs and recommend statistical and analytical strategies that optimize study efficiency and regulatory alignmentYou serve as a technical advisor within the disease area, mentoring statisticians and promoting quality standards and consistencyYou partner closely with clinical, regulatory, and data science teams to ensure statistical deliverables at the program level are scientifically robust, relevant, clearly communicated, and timelyYou keep abreast of new developments in drug development through evolving health authority guidance, literature review, conference attendance, and collaborative partnershipsYou drive the narrative of key results and support responses to health authority interactionsYou contribute to continuous improvement of statistical processes, templates, and tools within the functionYou mentor junior staffWho You Are:You hold an MSc or PhD in Statistics, Biostatistics, or a related quantitative fieldYou have a minimum of 12 years of experience in clinical development within the pharmaceutical, biotech, or healthcare sectorYou have a proven ability to lead statistical input into clinical development plans and regulatory submissionsYou bring strong expertise in applying advanced statistical methods to support data-driven decision-makingYou are proficient in SAS and/or R with deep familiarity with CDISC standards and evolving regulatory data requirementsYou have a track record of leading statistical execution and delivering results in a collaborative, team-oriented environmentYou have demonstrated experience with regulatory interactions and filingsYou bring strong expertise in clinical trial methodology and statistical principlesYou are familiar with innovative trial designsYou demonstrate capacity for independent thinking and ability to make decisions based upon sound principlesYou bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domainYou demonstrate respect for cultural differences when interacting with colleagues in the global workplaceYou have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear languageYou are able to effectively partner with stakeholders within and outside of PDDYou understand the different subfunctions of PDD and their contributions to drug developmentPreferred:Experience working in obesity, diabetes, and cardiovascular diseaseExperience working in cross-functional global study teamsExperience with multiple phases of drug development (early and/or late stage)Experience in mentoring or scientific leadership within a matrix organizationStrategic mindset with the ability to contribute to portfolio-level decisionsLocationThis position is based in South San Francisco and BostonGenentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.If you have a disability and need an accommodation in relation to the online application process, please contact us.