Statistician

Roche•Mississauga, ON

1d•CA$89,256 - CA$117,149•Onsite

About The Position

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 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.

Requirements

Hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
1-3 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
Familiarity with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA)
Strong understanding of statistical principles and methodology relevant to clinical trial design and analysis
Proficiency in SAS and/or R and familiarity with CDISC standards
Demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
Excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
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 cross-functional 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
Strategic mindset with the ability to contribute to portfolio-level decisions

Responsibilities

Contribute to trial design under guidance, applying standard statistical methods
Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents
Perform or support statistical analyses as per statistical analysis plans, escalating issues when needed
Represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance
Collaborate with study team members to meet deliverables, following existing processes
Summarize findings clearly with support from senior colleagues
Contribute to CSR development and regulatory responses using established templates
Apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations
Adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise