Principal Statistician, Early Development (ophthalmology)

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The Position

This role is in Early Development Biometrics (EDB), a core function within Product Development Data Science & Analytics (PDD) that provides strategic leadership and scientific rigour 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.

The Principal Statistician in Early Development is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigour while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analysing complex, often high-dimensional data to inform early go/no-go decisions, regulatory interactions, and shaping the early clinical narrative.

This role sits within the European Early Development Biometrics team (covering ophthalmology and immunology). The group has members in Basel (Switzerland) and Welwyn (UK). The primary responsibility of this role is for the ophthalmology portfolio.

The Opportunity

• You are responsible for multiple early phase molecules and lead the statistical design of complex or high-priority early phase studies.
• You champion the use of innovative methodologies, e.g. adaptive, platform, and biomarker-enriched trials, Bayesian designs and model-based dose selection.
• You mentor junior colleagues, both within statistics and cross-functionally, and take on matrix leadership roles within statistics.
• You ensure strategic alignment and quality across statistical deliverables within early phase programmes, shaping the statistical framework that supports phase transitions, internal governance reviews, and regulatory interactions.
• You solve complex statistical challenges in early development using deep expertise and novel approaches, such as integrating translational data, navigating sparse or emerging datasets, and balancing speed with scientific rigour.
• You interpret and drive the narrative around emerging data, translating early signals into clear, meaningful insights for internal stakeholders and external communications.
• You own the statistical content of major early regulatory submissions, such as INDs, EMA scientific advice packages, and pre-IND or End of Phase 1 meetings, ensuring clarity, integrity, and scientific robustness.
• You lead sub-streams and functional contributions within disease area strategy and the integration of novel data sources, for example omics, imaging, and real-world data (RWD).

Who You Are

• Education: PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field.
• Experience: 6+ years of experience in clinical trial statistics (including study- and molecule-level strategy and decision-making), preferably with Phase 1/2 experience.
• Strategic & Cross-Functional Leadership: Proven ability to lead statistical contributions for clinical development plans, study documents (protocol, SAP, CSR), dose selection, and regulatory submissions. May include portfolio-level decisions.
• Mentoring: Demonstrated ability to mentor junior colleagues in matrixed cross-functional teams, including instructing junior statisticians in statistical methodology, business processes, regulatory strategy, and drug development.
• Methodological Excellence: Demonstrated expertise in advanced/innovative statistical methods and ability to apply them to drug development problems, including both study design and data analysis.
• Technical Expertise: Proficient in R (preferably including SAS). Familiar with CDISC standards and evolving regulatory data requirements.
• Communication & Collaboration: Possess excellent verbal and written communication and collaboration skills for matrixed cross-functional teams. Ability to explain complex concepts to non-technical audiences. Demonstrate respect for cultural differences in a global workplace.
• Preferred: Clinical trial experience in ophthalmology. Exceptional candidates with strong early-phase experience across other therapeutic areas will also be considered.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

Who we are

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.

Roche is an Equal Opportunity Employer.