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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 Programmer develops high-quality, analysis-ready datasets and outputs that enable exploratory evidence generation in early-phase clinical trials. This role supports flexible and evolving study needs by creating custom data structures, outputs, and visualizations suited to novel or non-standard endpoints. Working within defined statistical analysis plans and programming conventions, the programmer ensures traceability, reproducibility, and technical rigor across diverse data sources. With strong proficiency in statistical programming and an understanding of early development challenges, this role helps deliver timely, fit-for-purpose outputs that inform development decisions and support transition into later-phase studies.
You independently design and implement statistical programming solutions for early phase clinical studies, including custom datasets, outputs, and visualizations that support exploratory analyses
You adapt and extend existing code libraries and standards to meet study specific requirements in settings with limited precedent or structure
You ensure traceability, reproducibility, and quality of programming deliverables through documentation, validation, and peer review
You identify potential data or programming issues early and proactively address them using structured problem solving approaches
You contribute to study planning and analysis specification by translating protocols and statistical analysis plans into actionable programming requirements
You participate in developing reusable tools, templates, and workflows that enhance efficiency across early phase studies
You provide informal technical guidance to junior programmers and collaborators when needed
You stay current on emerging tools, languages, and methods applicable to early phase statistical programming and contribute to internal knowledge sharing efforts
Who You Are:
You hold a Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field
You bring a minimum of 5 years of experience in statistical programming, preferably in clinical research or biomedical settings, or an advanced degree with 3 years of equivalent work experience
You are proficient in one or more programming languages (e.g., SAS, R, Python) with a demonstrated ability to develop, validate, and document custom outputs and datasets
You have experience working with exploratory or non standard data in early phase studies, including integrating and transforming diverse data types
You have a solid understanding of data quality, traceability, and reproducibility in the context of statistical reporting
You independently translate statistical analysis requirements into technical solutions
You demonstrate strong analytical thinking, attention to detail, and comfort working in environments with evolving protocols and endpoints
You communicate effectively in technical documentation and peer collaboration
You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
Preferred:
Hands-on experience with biomarkers, -omics, imaging, or other complex data types commonly encountered in early development
Familiarity with simulation-based or adaptive trial designs and their programming implications
Experience developing modular scripts or reusable code components across studies or programs
Understanding of early development timelines and the role of data outputs in enabling go/no-go or dose-escalation decisions
Exposure to data visualization tools or interactive exploration environments (e.g., Shiny, RMarkdown, Jupyter)
Active contribution to internal quality standards, automation tools, or innovation initiatives
Interest in expanding skills beyond coding, such as workflow optimization, pipeline development, or computational efficiency
Relocation benefits are not available for this posting
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Roche is an Equal Opportunity Employer.