ADS Lead, Early Development

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. • You oversee programming and analytical strategy across multiple early phase molecules or disease area programs, ensuring alignment with clinical hypotheses, translational objectives, and early regulatory needs (e.g., IND submissions, dose selection, go/no-go decisions) • You lead cross functional planning and delivery of programming outputs for Phase I/II trials, including rapid cycle interim analyses, safety reviews, and exploratory endpoint summaries, while ensuring agility, scientific flexibility, and high quality under accelerated timelines • You represent Analytical Data Science in early development governance, scientific advisory boards, and early regulatory interactions, helping define data strategy and ensuring programming readiness for evolving study designs and analysis requirements • You resolve complex technical and operational challenges typical of early development settings, such as integrating diverse data types (e.g., PK, biomarker, imaging), managing high iteration cycles, or handling incomplete or in flight datasets without compromising scientific integrity • You drive the adoption of flexible, modular programming frameworks and automation approaches, enabling reuse across early trials while maintaining adaptability to frequent design changes, exploratory objectives, and novel endpoints • You provide oversight and technical leadership for vendor partners, ensuring high quality and timely programming deliverables that align with the fast paced needs of early phase programs and exploratory analysis goals • You shape the broader Product Development Data Science agenda by representing the early development programming perspective in cross functional governance forums and contributing to enterprise wide strategies on data integration, standards, and innovation adoption • You lead a team of Analytical Data Scientists supporting early phase studies, managing workload allocation, performance, and career development while fostering adaptability in a fast paced, hypothesis driven environment • You set team strategy and short term priorities in alignment with early development program needs, allocating resources effectively across complex and evolving studies within constrained timelines and budgets • You build and sustain a high performing, agile team, identify future facing skills (e.g., automation, data integration, biomarker analytics), drive upskilling, and cultivate a culture of scientific rigor, innovation, and collaboration • You provide clear guidance in ambiguous situations, helping the team navigate shifting study designs, accelerated timelines, and exploratory analyses by offering structure, support, and context driven prioritization • You serve as the primary point of accountability for team delivery, ensuring outputs (e.g., SDTM/ADaM datasets, tables, figures, listings, exploratory outputs) meet expectations for scientific quality, regulatory compliance, and timeliness even in the face of early phase complexity Who You Are: • You hold an advanced degree (Master’s or PhD) in Statistics, Biostatistics, Computer Science, Life Sciences, or a related quantitative field • You bring a minimum of 12 years of experience in statistical and analytical programming within clinical development, with demonstrated impact across multiple programs or therapeutic areas • You have deep expertise in clinical trial data standards (e.g., CDISC SDTM and ADaM), regulatory submission requirements, and end to end data workflows • You have a proven track record of leading cross functional data delivery for complex clinical programs, including regulatory submissions • You are proficient in programming languages and tools commonly used in clinical data analysis (e.g., SAS, R, Python), with experience implementing scalable, reusable, and automated solutions • You have a strong understanding of global regulatory expectations and experience representing programming in interactions with health authorities • You demonstrate the ability to lead large scale initiatives and resolve complex technical challenges with minimal guidance • You have experience contributing to functional innovation, including the adoption of new tools, standards, or delivery models • You demonstrate respect for cultural differences when interacting with colleagues in the global workplace Relocation benefits are not available for this posting The expected salary range for this position based on the primary location of California is $166,700.00 - $309,700.00.

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