Senior Statistician
A 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 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.
Key Responsibilities
A 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 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.
Key Responsibilities
- 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
- You hold an MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
- You have a confirmed 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
- 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
Vacancy posted 8 days ago
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