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 PositionThis 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 cutting‑edge 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 OpportunityThe 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.You contribute to trial design under guidance, applying standard statistical methodsYou draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedentsYou perform or support statistical analyses as per statistical analysis plans, escalating issues when neededYou represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidanceYou collaborate with study team members to meet deliverables, following existing processesYou summarize findings clearly with support from senior colleaguesYou contribute to CSR development and regulatory responses using established templatesYou apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situationsYou adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertiseWho You AreYou hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative fieldYou have 1-3 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech,



or CRO settingYou are familiar with ICH guidelines, GCP, and regulatory requirements (e.G., FDA, EMA)You have a strong understanding of statistical principles and methodology relevant to clinical trial design and analysisYou are proficient in SAS and/or R and familiar with CDISC standardsYou demonstrate capacity for independent thinking and ability to make decisions based upon sound principlesYou bring excellent strategic agility including problem‑solving and critical thinking skills, and agility that extends beyond the technical domainYou demonstrate respect for cultural differences when interacting with colleagues in the global workplaceYou have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear languagePreferredExperience working in cross‑functional teamsEffective communication skills with the ability to translate complex statistical concepts for non‑statistical audiencesExperience 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 stakeholdersStrategic mindset with the ability to contribute to portfolio‑level decisionsRelocation advantages are not available for this posting.The expected salary range for this position based on the primary location of Mississauga is 89,256.00 to 117,148.50. Actual pay will be determined based on experience, qualifications, and other job‑related factors as determined by the company.This posting is for an existing vacancy at Hoffmann‑La Roche Ltd.Roche is an Equal Opportunity Employer.#J-18808-Ljbffr

📌 Statistician (Mississauga) - C$89,256 - C$117,148.5 A Year (Winnipeg)
🏢 Roche
📍 Winnipeg