Statistician, Early Development

Location: Welwyn

Statistician, Early Development page is loaded## Statistician, Early Development locations:
Welwyntime type:
Full time posted on:
Posted Todayjob requisition :
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 Position

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 statistics 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.
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* 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 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 statistical analysis plans, 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 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…