Join our team as a Senior ADS Programmer, where you will transform statistical analysis plans into high-quality programming deliverables for clinical trials. You will independently develop and validate datasets, ensuring compliance with regulatory standards. Ideal candidates have significant experience in statistical programming within clinical development and strong expertise in modern programming languages and data analysis.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
Tasks
- Transform statistical analysis plans into high-quality, traceable programming deliverables, including static and dynamic outputs such as tables, listings, figures, and interactive data visualizations or dashboards.
- Create and validate datasets in accordance with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards, ensuring compliance with regulatory requirements and Roche standards.
- Support regulatory submissions and generate data insights through platforms such as the Insight Engine, enabling real-time exploration and interpretation of diverse clinical and exploratory data.
- Independently develop, validate, and maintain datasets and statistical outputs for clinical trials, ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations.
- Develop and support programming outputs across a wide range of data types, including exploratory biomarker data and real-world data, to support both regulatory and scientific objectives.
- Collaborate on exploratory analyses that span disease areas and therapeutic areas, enabling insight generation to inform drug development strategies.
- Support the creation and refinement of interactive tools and analytical applications (e.g., dashboards or visual data platforms) that enable dynamic exploration of integrated datasets by scientific and clinical teams.
- Provide programming leadership for assigned studies, coordinating deliverables across internal and external programming partners to meet study timelines and requirements.
- Interpret statistical analysis plans and translate them into executable programming specifications to ensure scientific rigor in outputs.
- Troubleshoot and resolve technical programming challenges with limited supervision, proactively identifying risks and implementing effective solutions while meeting timelines.
- Contribute to the design and maintenance of standard macros and reusable components, promoting efficiency and consistency across multiple studies and projects.
- Document programming workflows and maintain audit trails, ensuring study files are complete, traceable, and inspection-ready.
- Work cross-functionally with stakeholders, including biostatistics, data management, and clinical operations, to define programming timelines and deliverables.
- Engage in process improvement and innovation activities and participate in learning activities to grow knowledge of clinical research and programming standards.
Requirements
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
- Minimum of 5 years of experience in statistical programming in a clinical development setting, or an advanced degree with 3 years of equivalent work experience.
- Proficient in or have working knowledge of a modern programming language (such as SAS or R) and visualization/review tools.
- Deep understanding of statistical quality, endpoints, and QC processes.
- Experience with Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., SDTM and ADaM).
- Expertise in handling and analyzing different types of data (multi-modal).
- Demonstrated ability to deliver programming outputs independently.
- Demonstrate respect for cultural differences when interacting with colleagues in the global workplace.
- Fluent in English.
- Preferred: Attention to detail for regulatory submission processes and related documentation.
- Preferred: Critical thinking, strong organizational and problem-solving skills.
- Preferred: Experience working in cross-functional global study teams.
- Preferred: Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences.
- Preferred: Experience with multiple phases of drug development (early and/or late stage).
- Preferred: Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders.
- Preferred: Demonstrated willingness to adapt, grow, and evolve in response to shifting priorities.
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Über uns
Das Team
This role is in Analytical Data Science, a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across Development at Roche. PDD Analytical Data Science teams generate data-driven insights, identify opportunities for scale, and implement impactful solutions, operating as an agile workforce to deliver regulatory commitments across the portfolio.