Senior Statistician

GenentechBoston, MA
Onsite

About The Position

The Senior Statistician role is a key member of the cross-functional study or molecule team within Biostatistics, a core function of Product Development Data Science and Analytics (PDD) at Roche. Biostatistics provides strategic leadership and scientific rigor across Development, leveraging data, digital, and design capabilities to deploy innovative methods. As trusted analytical partners in end-to-end drug development, Biostatistics drives scientifically rigorous programmatic decisions, designs robust trials, and accelerates timelines to advance Roche’s clinical pipeline and promote regulatory success. The Senior Statistician applies statistical expertise to the design, conduct, analysis, and interpretation of individual clinical trials, ensuring scientific rigor and regulatory compliance. This involves contributing to protocol development, authoring statistical analysis plans, performing or overseeing data analyses, and supporting the interpretation and communication of results to generate robust, meaningful data for decision-making and regulatory submissions.

Requirements

  • Hold an 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
  • Proficient in SAS and/or R and familiar with CDISC standards
  • Able to work autonomously while collaborating effectively in cross-functional teams
  • Demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
  • Bring 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

Nice To Haves

  • Experience working in CVRM diseases
  • Experience working in cross-functional global study teams
  • Effective communication skills with the 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

Responsibilities

  • 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 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

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance
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