Senior Principal Statistical Methodologist
Role details
Job location
Tech stack
Job description
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
Requirements
Do you have experience in Data science?, Do you have a Doctoral degree?, * 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