Principal Statistician, Early Development (ophthalmology)

1201 F. Hoffmann-La Roche AG; Basel; On-site; CHF 150,000 - 210,000; Full time

Job summary

Roche is seeking a Principal Statistician in Early Development to lead statistical design and analysis for first-in-human and early-phase studies. You will collaborate across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decisions and robust regulatory submissions.

Mentoring and innovative statistical approaches are central to the role. You will partner with ophthalmology and immunology teams, contribute to complex trial designs, and shape the statistical

Qualifications

• PhD or MSc in Statistics, Biostatistics, or closely related field.
• 6+ years in clinical trial statistics, Phase 1/2 experience preferred.
• Strong leadership in cross-functional teams and regulatory submissions.
• Proficiency in R (preferably with SAS) and familiarity with CDISC standards.

Responsibilities

• Contribute to protocol design and develop SAP/CSR.
• Analyse complex data to inform early go/no-go decisions and regulatory interactions.
• Lead statistical framework design for early phase programmes and regulatory submissions.
• Mentor junior statisticians and provide cross-functional leadership within the team.

Skills

Statistical leadership

Clinical trial statistics

Mentoring

Adaptive/Bayesian designs

R & SAS

CDISC standards

Communication

Cross-functional collaboration

Education

PhD/MSc in Statistics/Biostatistics

Tools

R

SAS

CDISC standards

Job description

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

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.

Where pay transparency applies, details are provided based on the primary posting location.

For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.