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Senior Principal Statistician

F. Hoffmann-La Roche AG

Senior Principal Statistician A healthier future drives us to innovate. This role lies within Biostatistics, a core function of Product Development Data Science and Analytics (PDD) at Roche. It provides strategic leadership and scientific rigor across development, leveraging data, digital, and design capabilities to support our clinical pipeline and regulatory success. Responsibilities Apply statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials. Ensure scientific rigor and regulatory compliance by contributing to protocol development, authoring statistical analysis plans, and overseeing data analyses. Support interpretation and communication of results, 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. Consult on challenging design or analysis questions and recommend 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 deliverables are scientifically robust, relevant, and timely. Stay abreast of new developments in drug development and regulatory guidance, and contribute to continuous improvement of statistical processes, templates, and tools. Qualifications MSc or PhD in Statistics, Biostatistics, or a related quantitative field. Minimum 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 advanced statistical methods, SAS or R, CDISC standards, and evolving regulatory data requirements. Track record of leading statistical execution and delivering results in a collaborative, team‑oriented environment. Experience with regulatory interactions and filings. Expertise in clinical trial methodology and statistical principles, and familiarity with innovative trial designs. Independent thinking and ability to make decisions based on sound principles. Excellent strategic agility, problem‑solving, and critical‑thinking skills. Respectful of cultural differences and strong verbal and written communication skills, including the ability to explain complex concepts in clear language. Effective partnership with stakeholders within and outside of PDD. Knowledge of the different subfunctions of PDD and their contributions to drug development. Preferred Qualifications Experience working in obesity, diabetes, and cardiovascular disease. Experience with 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 ability to contribute to portfolio‑level decisions. Location This position is based in South San Francisco and Boston. Equal Opportunity Employer. Genentech, a member of the Roche Group, is an equal opportunity employer. We are committed to offering opportunities on the basis of merit, qualifications, and competence, in compliance with all federal, state, and local laws. #J-18808-Ljbffr F. Hoffmann-La Roche AG

Vacancy posted 5 days ago
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