Senior Principal Statistician - Biostatistics

About the role

Roche's Biostatistics function, part of Product Development Data Science and Analytics (PDD), leads scientific rigor across drug development. As a Senior Principal Statistician you will be a key member of a cross-functional study or molecule team, applying statistical expertise to the design, conduct, analysis and interpretation of clinical trials, and ensuring the scientific rigor and regulatory compliance of each study.

Key responsibilities

• Own the strategy and execution of all statistical aspects of a molecule program, including digital, design and data capabilities
• Represent PDD on cross-functional teams such as the Development and Lifecycle Team
• Ensure consistency, scientific rigor and regulatory readiness of protocols, statistical analysis plans, outputs and submissions
• Lead statistical design and strategy for the molecule CDP, and advise cross-functional teams on study design, analysis and interpretation
• Work independently on challenging design or analysis questions, interpreting business or regulatory needs and recommending strategies
• Act as a technical advisor in the disease area, mentoring statisticians and promoting quality standards
• Partner with clinical, regulatory and data science teams, and help shape responses to health authority interactions
• Contribute to publications, presentations and continuous improvement of statistical processes, templates and tools

Required profile

• MSc or PhD in Statistics, Biostatistics or a related quantitative field
• At least 12 years of experience in clinical development in pharma, biotech or healthcare
• Proven ability to lead statistical input into clinical development plans and regulatory submissions
• Track record of regulatory interactions and filings, and of mentoring junior staff
• Excellent communication skills, strategic agility and respect for cultural differences in a global workplace

Required skills

• Proficiency in SAS and/or R
• Deep familiarity with CDISC standards and evolving regulatory data requirements
• Expertise in clinical trial methodology, statistical principles and innovative trial designs

Preferred: experience in obesity, diabetes and cardiovascular disease; cross-functional global study teams; multiple phases of drug development; mentoring in a matrix organization; portfolio-level strategic thinking. The position is based in South San Francisco and Boston.