Statistician

F. Hoffmann-La Roche Gruppe; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Mississauga is seeking a Statistician to apply statistical expertise in clinical trials. The role involves trial design, analysis, and supporting regulatory submissions. Candidates should have an MSc or PhD in Statistics with 1-3 years of experience in related fields. Strong communication and statistical analysis skills are essential. The position offers a dynamic environment in a globally impacting company.

Qualifications

• 1-3 years of relevant experience in clinical trial statistics.
• Familiarity with ICH guidelines, GCP, and regulatory requirements.
• Strong understanding of statistical principles relevant to clinical trial design.

Responsibilities

• Contribute to trial design under guidance using standard statistical methods.
• Draft and review protocols and statistical analysis plans.
• Perform or support statistical analyses as per SAPs.

Skills

Independent thinking

Problem-solving skills

Communication skills

Statistical analysis

SAS

R

Education

MSc or PhD in Statistics, Biostatistics, or related field

Tools

SAS

R

Job description

The Position

A healthier future drives Roche to innovate. This role is within Biostatistics, a core function within Product Development Data Science and Analytics (PDD). Biostatistics provides strategic leadership and scientific rigor across Development, identifying opportunities to apply 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 designs robust trials and analysis plans that increase the probability of technical success, accelerate timelines, and promote regulatory success to bring medicines to 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 scientific rigor and regulatory compliance by contributing to protocol development, drafting statistical analysis plans, performing or overseeing data analyses, and supporting interpretation and communication of results. The Statistician helps ensure each study generates robust, meaningful data to support decision-making and regulatory submissions.

• You contribute to trial design under guidance, applying standard statistical methods
• You draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents
• You perform or support statistical analyses as per SAPs, escalating issues when needed
• You represent Biostatistics and PDD at the Study Team level, ensuring statistical and scientific rigor of study deliverables under guidance
• You collaborate with study team members to meet deliverables, following existing processes
• You summarize findings clearly with support from senior colleagues
• You contribute to CSR development and regulatory responses using established templates
• You 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
• You adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise

Who You Are:

• You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
• You have 1-3 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
• You 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 analysis
• You are proficient in SAS and/or R and familiar with CDISC standards
• You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
• You bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
• You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
• You have excellent verbal and written communication skills, specifically in presentation and writing, with the ability to explain complex technical concepts in clear language

Preferred:

• 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

Relocation benefits are not available for this posting

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Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing 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.