Senior Biostatistician

The role is within Biostatistics, a core function of Product Development Data Science and Analytics (PDD) that provides strategic leadership and scientific rigor across Development at Roche. Biostatistics identifies opportunities to apply data, digital, and design capabilities to deploy innovative methods, ensuring robust trials and analysis plans that increase the probability of technical success, accelerate timelines, and promote regulatory success—ultimately bringing medicines to patients faster.

About the role

The Senior 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 scientific rigor and regulatory compliance by contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results.

• Independently lead statistical input into clinical trial design, aligning with scientific objectives.
• Own the development and quality review of statistical study documents.
• Design and execute complex analyses, proactively resolving challenges.
• Represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables.
• Collaborate proactively with cross-functional teams to align deliverables and timelines.
• Interpret and communicate results in context, influencing study-level decisions.
• Lead statistical contributions to Clinical Study Reports (CSRs) and selected regulatory documents.
• Provide functional guidance and informal mentoring to less experienced statisticians.
• May lead or influence study-level projects or contribute significantly to large project teams or initiatives.

Requirements

• MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 3 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting.
• Demonstrated experience contributing to the design, analysis, and interpretation of clinical studies across different phases.
• Solid understanding of regulatory expectations and statistical methodologies for clinical development.
• Proficiency in SAS and/or R and familiarity with CDISC standards.
• Ability to work autonomously while collaborating effectively in cross-functional teams.
• Capacity for independent thinking and decision-making based on sound principles.
• Excellent strategic agility, problem-solving, and critical thinking skills.
• Respect for cultural differences in a global workplace.
• Excellent verbal and written communication skills, with the ability to explain complex technical concepts clearly.

Preferred Qualifications

• Experience with late-stage clinical trials.
• Experience in Oncology and/or Ophthalmology.
• Experience working in cross-functional global study teams.
• Ability to translate complex statistical concepts for non-statistical audiences.
• 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.

Pay

The expected salary range for this position based on the primary location of California is $136,900 - $254,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link.