Biostatistics Oncology Lead, Early Development

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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, anticipating future needs and adjusting as priorities evolve

• You collaborate with Early Development Biometrics and PD-DSA leadership to define role expectations, career paths, and performance standards for statistical talent

• You partner with People & Culture (P&C) to attract, retain, and onboard diverse statistical talent aligned with the future needs of early development

• You act as a role model for Roche’s leadership commitments, embracing a growth mindset and empowering team members to lead from every seat

Who you are:

• You hold a PhD or equivalent advanced degree in Statistics, Biostatistics, or a related quantitative discipline

• You bring 15+ years of experience in statistical roles in pharmaceutical, biotech, or clinical research settings, including substantial experience in early clinical development

• You have a proven track record of statistical leadership across multiple studies and programs, with impact on early phase design, strategy, and decision making

• You have strong expertise in clinical trial design, Bayesian and adaptive methods, and statistical modeling under uncertainty

• You demonstrate the ability to lead and develop statistical teams, fostering scientific excellence and individual growth

• You have a deep understanding of the unique challenges and scientific opportunities in early phase drug development, including exploratory endpoints, high dimensional data, and translational research

• You communicate complex statistical concepts clearly and think strategically, translating them into actionable insights

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

Preferred Qualifications:

• Experience leading statistical contributions to early development strategies, including dose finding, proof-of-concept, and translational study design

• Familiarity with modern data types and exploratory analysis techniques, including biomarkers, -omics, imaging, or real-world data

• Demonstrated application of Bayesian methods, modeling and simulation, or model-informed drug development in early-phase settings

• Engagement with regulatory agencies, scientific consortia, or external partners on topics related to early development analytics

• Experience shaping internal best practices, frameworks, or standards for statistical excellence and reproducibility

• Strong interest in or experience with digital innovation, AI/ML, or advanced data science methods applicable to early-phase research

• Proven ability to lead through ambiguity and influence across organizational boundaries in a matrixed and evolving environment

• Recognized contributor to internal scientific communities or external forums (e.g., publications, conferences, working groups)

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $207,100.00 - $384,500.00.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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