At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionA 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 Principal 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.
Shape and execute the statistical strategy for molecule programs, driving innovation with digital, design, and data capabilities.
Represent PDD in key cross-functional teams, ensuring scientific rigor and regulatory readiness across statistical deliverables.
Lead statistical designs for complex and priority studies, applying innovative methodologies and solving challenging statistical problems.
Interpret key results and drive impactful narratives for internal and external stakeholders, including major regulatory submissions.
Ensure strategic alignment and consistency across programs, submissions, and statistical deliverables with a focus on quality.
Contribute to publications, presentations, and collaboration with scientific and methodological communities.
Mentor junior staff and lead sub-streams or functional contributions in global, large-scale cross-functional initiatives.
Who You Are:
You have a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field, with 7+ years of experience in clinical trial statistics, including study-level strategy and decision-making.
Lead statistical contributions to clinical development plans and regulatory submissions, bringing expertise in advanced statistical methods to drive data-driven decision-making.
Demonstrate proficiency in SAS and/or R, with deep familiarity with CDISC standards and evolving regulatory data requirements.
Exhibit strategic agility, problem-solving, and independent thinking, complemented by excellent communication skills to articulate complex technical concepts clearly.
Partner effectively with global stakeholders, respecting cultural diversity and enabling collaboration within and beyond PDD.
Preferred:
Therapeutic experience in CVRM (Cardiovascular, Renal, and Metabolism) or Hematology/Oncology
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)
Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders
Experience in mentoring or scientific leadership within a matrix organization
Strategic mindset with the ability to contribute to portfolio-level decisions
Relocation Benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
