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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 Early Development ADS Lead as a senior leader within the Early Development function, responsible for shaping and executing the analytical data science strategy across multiple clinical programs or an entire therapeutic area. The incumbent leads a team of highly skilled programmers and junior leaders, ensuring the timely delivery of high-quality, regulatory-compliant analytical outputs that underpin key development milestones and health authority submissions.
Beyond overseeing day-to-day operations, this role defines priorities, manages resource allocation, and drives the scalability and sustainability of programming activities through process standardization, automation, and innovation. The role is integral to cross-functional planning and governance, acting as a trusted strategic partner to stakeholders across Product Development Data Science (PDD) and broader clinical development.
As a people leader, this position is accountable for building and nurturing talent, fostering a culture of technical excellence and continuous learning, and ensuring strong alignment with both functional objectives and enterprise-wide data strategies.
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
Preferred Qualifications:
Experience leading programming strategy for global regulatory submissions, including preparation of early integrated summaries (e.g., ISS/ISE) to support initial regulatory interactions and scientific advice packages.
Familiarity with metadata-driven programming approaches and data standards (e.g., CDISC SDTM/ADaM) applied flexibly to accommodate the exploratory and evolving nature of early-phase trials.
Proven ability to drive functional innovation by implementing automation, process improvements, and adoption of emerging programming tools (e.g., cloud computing, containerization, AI-assisted coding) to accelerate delivery and improve quality in early development.
Exposure to real-world data (RWD), digital health technologies, or wearable device data integration within early clinical development, facilitating incorporation of novel endpoints and patient-centric data streams.
Active participation in industry working groups, consortia, or contribution to programming standards and best practices, demonstrating thought leadership and a commitment to advancing the field; especially in early development contexts.
Strong understanding of adaptive designs and complex early-phase study data structures, enabling development of flexible programming solutions that support rapid data iteration and decision-making.
Experience collaborating closely with Biostatistics and Data Management teams to ensure smooth data flow, traceability, and alignment on interim and final data deliverables critical to early-phase decision points.
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. 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.
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