Senior Principal Statistician, Early Development (Director Level)

About the role

Early Development Biometrics (EDB) is a core function of Product Development Data Sciences that provides strategic leadership and scientific rigor across early clinical development, partnering with Biostatistics, Analytical Data Science and Data Management. The Senior Principal Statistician leads the statistical design and strategy of complex early-phase studies (first-in-class, seamless Phase I/II trials, novel platform designs) and acts as a primary statistical advisor for therapeutic area strategy.

Key responsibilities

• Contribute to protocol design, develop statistical analysis plans and analyze complex, high-dimensional data to inform early go/no-go decisions and regulatory interactions
• Lead statistical design and strategy of complex early-phase studies and programs, aligned with exploratory goals and translational hypotheses
• Serve as primary statistical advisor for therapeutic area strategy and shape portfolio decisions
• Integrate multimodal data such as biomarkers, imaging and real-world data into early trial design and analysis
• Represent the function in senior governance discussions on dose or regimen optimization, early investment and progression to later stages
• Co-lead cross-functional initiatives, including standardization of adaptive design approaches and decision-making frameworks
• Guide statistical content of regulatory engagements (e.g., EMA Scientific Advice, FDA EoP1) and author key statistical components of submission packages
• Provide technical leadership to statisticians and colleagues, propose and evaluate new methods, and support enterprise-level modeling and AI/ML efforts

Required profile

• PhD or MSc in Statistics, Biostatistics or a closely related quantitative field
• Minimum 12 years of experience in clinical trial statistics, including advanced contributions to early development strategy
• Recognized expertise in advanced statistical design and modeling (e.g., Bayesian adaptive trials, model-based decision-making)
• Proven leadership in high-impact cross-functional projects across multiple molecules or disease areas
• Excellent communication skills with the ability to influence senior clinical and regulatory stakeholders
• Independent thinking, strategic agility and respect for cultural differences in a global workplace

Preferred: experience leading disease area statistical strategy or representing the function in enterprise-level initiatives; familiarity with AI/ML, real-world data or novel data sources; contributions to external working groups, scientific collaborations or published statistical innovation.

What we offer

• Expected salary range of $171,600 - $318,600 for the California location, depending on experience, qualifications and location
• A discretionary annual bonus may be available
• The position qualifies for the benefits described in the original listing
• Relocation benefits are not available for this posting