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.
A healthier future. Its 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. Thats 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 Roches Development portfolio; Biostatistics designs robust trials and analysis plans that increase the probability of technical success accelerating timelines to advance Roches clinical pipeline and promote regulatory success ultimately bringing medicines to our patients faster.
The Opportunity:
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.
You independently lead statistical input into clinical trial design aligning with scientific objectives
You own the development and quality review of statistical study documents
You design and execute complex analyses proactively resolving challenges
You represent Biostatistics and PDD at the Study Team level ensuring statistical and scientific rigor of study deliverables
You collaborate proactively with cross-functional teams to align deliverables and timelines
You interpret and communicate results in context influencing study-level decisions
You lead statistical contributions to CSRs and selected regulatory documents
You provide functional guidance and informal mentoring to less experienced statisticians
You may lead or influence study-level projects or contribute significantly to large project teams or initiatives
Who You Are:
You hold an MSc or PhD in Statistics Biostatistics or a closely related quantitative field
You have a minimum of 5-7 years of relevant experience in clinical trial statistics within a pharmaceutical biotech or CRO setting
You have demonstrated experience contributing to the design analysis and interpretation of clinical studies across different phases
You have a solid understanding of regulatory expectations and statistical methodologies for clinical development
You are proficient in SAS and/or R and familiar with CDISC standards
You are able to work autonomously while collaborating effectively in cross-functional teams
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 the areas of presentation and writing with the ability to explain complex technical concepts in clear language
Preferred:
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
Relocation benefits are not available for this posting
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The expected salary range for this position based on the primary location of Mississauga is 115328.00 and 151368.00 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.
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.