Biostatistics Oncology Lead, Early Development

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 Methods Collaboration & Outreach (MCO), 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 Biostatistics Oncology Lead in Early Development Biometrics provides scientific and strategic leadership for biostatistical contributions across a therapeutic area within early-phase clinical development. Operating in a high-uncertainty, fast-paced setting, this role ensures that statistical approaches used across programs are rigorous, innovative, and tailored to enable confident early development decisions.

In this role, you will shape the statistical strategy across multiple programs, define best practices for study design and evidence generation, and drive methodological excellence in exploratory and translational contexts. You will serve as the primary biostatistics representative within Early Development Biometrics for your therapeutic area, ensuring scientific alignment, quality, and readiness for progression into later development stages.

• You provide scientific and strategic biostatistics leadership across early phase studies and programs, ensuring methods are rigorous, decision enabling, and aligned

• You define fit for purpose statistical approaches for study design, endpoint selection, and data interpretation across exploratory and translational settings

• You guide the application of innovative methodologies such as Bayesian methods, simulation, and adaptive designs to support early decision making under uncertainty

• You ensure high quality, reproducible statistical deliverables across studies, aligned with internal best practices and external expectations

• You act as the biostatistics point of accountability for the therapeutic area within EDB, engaging in program level strategy and planning

• You promote consistent, scalable statistical practices by contributing to internal frameworks, standards, and tool development

• You represent biostatistics in cross program discussions and EDB leadership forums, helping shape function wide direction and priorities

• You advance early development analytics by integrating modern statistical tools, AI/ML, and data science capabilities

• You lead, mentor, and develop a high performing team of biostatisticians across early phase programs within the therapeutic area

• You foster a culture of scientific excellence, accountability, and continuous learning by setting clear expectations, providing ongoing feedback, and recognizing performance

• You create an inclusive and psychologically safe team environment that encourages open dialogue, curiosity, and innovation

• You support the professional development of team members through coaching, targeted opportunities, and succession planning

• You ensure appropriate resourcing and workload balance across studies and programs, anticipat