Senior Principal Statistical Methodologist

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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 in Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across early clinical development at Roche. We partner across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decision-making from first-in-human through proof-of-concept studies.

As trusted partners in early development, we design efficient and innovative clinical trials, apply rigorous statistical methods, and implement high-quality programming and analytical solutions to accelerate timelines, de-risk development, and increase the probability of technical success. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas. Together, we bring scientific rigor, technical innovation, and strategic insight to shape the future of early development and deliver better outcomes for patients.

Early Development Biometrics is also home to the Statistical Methodology group, which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high-quality Medical Data Review (MDR) and safety signal detection, aligned with Risk-Based Quality Management (RBQM) principles and Critical-to-Quality (CtQ) endpoints.
 

The Opportunity: 

The Statistical Methodology Data Scientists play a strategic role in enabling the adoption of fit-for-purpose statistical methodologies to drive scientific rigor and decision-making excellence in early clinical development. This team serves as a center of excellence focused on consultation, education, and outreach to ensure that innovative and appropriate methods are applied across programs and portfolios.

Statistical Methodology Data Scientists collaborate closely with project teams, biostatisticians, and cross-functional stakeholders to identify methodological needs, prototype solutions (e.g., estimand frameworks, trial simulations, covariate adjustment strategies), and support scalable adoption through training, templates, and tools. They engage in portfolio-level analyses, scenario modeling, and quantitative frameworks that inform go/no-go decisions and optimize clinical strategy.

The team also maintains key external relationships, representing the company in consortia, scientific working groups, and regulatory collaborations to stay at the forefront of methodological advances in the pharmaceutical industry.

• You act as a recognized expert in statistical methodology for early development, leading complex methodological initiatives and providing strategic consultation across multiple therapeutic areas and programs

• You anticipate emerging scientific and regulatory trends in clinical trial design, decision-making, and statistical modeling, and proactively recommend and implement innovative solutions across EDB and PDD

• You lead the design and delivery of scalable tools, templates, and decision frameworks that shape the consistent application of quantitative methods in early-phase trial strategy and portfolio analytics

• You drive internal capability building by setting standards and co-leading education efforts on advanced methods (e.g., Bayesian frameworks, causal inference, adaptive designs) and their translational relevance

• You provide senior advisory support to project teams, therapeutic area leadership, and governance bodies on high-impact analytical challenges, including estimand definition, go/no-go frameworks, and multi-source data integration

• You represent Early Development Biostatistics in cross-functional working groups, strategic initiatives, and methodological innovation forums, guiding decision-making and enabling enterprise-wide impact

• You serve as a key contributor to external scientific engagements (e.g., publications, consortia, regulatory workshops), shaping the methodological landscape and Roche’s visibility in early-phase analytics

• You collaborate with biostatistics, data science, clinical, and regulatory leaders to align methodological innovation with program priorities, ensure technical excellence, and address cross-cutting challenges across development programs

Who you are:

• You hold a PhD (or equivalent experience) in Statistics, Data Science, Computer Science, Bioinformatics, or a related quantitative discipline

• You have significant experience applying statistical methodologies in early clinical development, translational science, or related domains.You demonstrate leadership in the development and deployment of fit-for-purpose statistical approaches across complex early-phase or exploratory programs

• You are recognized as an internal or external expert in one or more methodological domains (e.g., trial simulation, longitudinal modeling, decision-support frameworks)

• You bring strong experience working with multi-modal or high-dimensional data in uncertain, fast-paced environments

• You show proven ability to lead cross-functional initiatives, influence strategic direction, and guide senior stakeholders on the application of advanced statistical methods

• You possess excellent communication and scientific writing skills, including the ability to convey complex ideas to senior leadership and cross-functional audiences

• You show respect for cultural differences when interacting with colleagues in the global workplace

Preferred:

• External visibility through publications, conference participation, or working group leadership in applied methodology or early-phase analytics

• Experience with tools or workflow design for scalable analytics (e.g., reusable simulation frameworks, adaptive design platforms)

• Familiarity with real-world data, digital endpoints, or patient-reported outcomes in early development contexts

• Track record of shaping internal methodological strategy or governance efforts within a clinical development organization

• Strong interest in bridging scientific rigor with operational feasibility to deliver impactful and innovative solutions

We look forward to your application.

This role is based on site at our Welwyn, United Kingdom office. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week.

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.