Senior ADS Programmer

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Health insurance

Wellness programs

Zusammenfassung

Roche is seeking a Senior ADS Programmer in Basel to transform statistical analysis plans into high‑quality programming outputs, including SDTM/ADaM datasets and tables, listings, and figures. The role supports regulatory submissions and data insights across clinical programs.

You will independently develop, validate, and maintain datasets for SDTM/ADaM, collaborate with biostatistics, data management, and clinical operations, and drive quality, traceability, and regulatory compliance across

Qualifikationen

• 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 a higher degree with 3+ years of experience.
• Proficiency in SAS or R and visualization/review tools.
• Deep understanding of statistical quality, endpoints, and QC processes.
• Experience with CDISC SDTM/ADaM standards.
• Experience handling multi-modal data and delivering independent outputs.

Aufgaben

• Transform statistical analysis plans into high‑quality, traceable programming deliverables (tables, listings, figures, dashboards).
• Develop and validate SDTM/ADaM datasets and TLFs per regulatory standards.
• Support regulatory submissions and generate data insights via platforms like the Insight Engine.
• Provide programming leadership and coordinate with internal and external partners across studies.
• Document workflows and maintain audit trails for inspection readiness.

Ausbildung

Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field

Jobbeschreibung

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. Join Roche, where every voice matters. The Position Senior ADS Programmer A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 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 are mobilized across the portfolio to generate data-driven insights, identify opportunities for scale, and implement impactful solutions. PDD Analytical Data Science is recognized as a leading hub for top industry talent, operating as an agile workforce to deliver regulatory commitments across the portfolio. We identify, influence, and adopt industry-leading digital and automation solutions, develop analytical approaches to support exploratory analyses, and align statistical programming practices across both early- and late-stage clinical development.

The Opportunity: The Analytical Data Science Programmer is a key contributor to the clinical study team, responsible for transforming statistical analysis plans into high-quality, traceable programming deliverables. This includes both static and dynamic outputs, such as tables, listings, figures, and interactive data visualizations or dashboards. The role involves creating and validating datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with regulatory requirements and Roche standards. In addition to supporting regulatory submissions, the ADS Programmer plays a critical role in generating data insights through platforms such as the Insight Engine, enabling real-time exploration and interpretation of diverse clinical and exploratory data. This role contributes to a modern, insight-driven development environment by facilitating robust, timely, and decision-enabling analytics across clinical programs.

You independently develop, validate, and maintain datasets and statistical outputs for clinical trials, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations. You 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. You collaborate on exploratory analyses that span disease areas and therapeutic areas, enabling insight generation to inform drug development strategies. You 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. You provide programming leadership for assigned studies, coordinating deliverables across internal and external programming partners to meet study timelines and requirements. You interpret statistical analysis plans and translate them into executable programming specifications to ensure scientific rigor in outputs. You troubleshoot and resolve technical programming challenges with limited supervision, proactively identifying risks and implementing effective solutions while meeting timelines. You contribute to the design and maintenance of standard macros and reusable components, promoting efficiency and consistency across multiple studies and projects.

You document programming workflows and maintain audit trails, ensuring study files are complete, traceable, and inspection-ready. You work cross-functionally with stakeholders, including biostatistics, data management, and clinical operations, to define programming timelines and deliverables. You engage in process improvement and innovation activities and participate in learning activities to grow knowledge of clinical research and programming standards.

Who you are:

• You hold a Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field
• You have a 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
• You are proficient in or have working knowledge of a modern programming language (such as SAS or R) and visualization/review tools
• You have a deep understanding of statistical quality, endpoints, and QC processes
• You have experience with Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., SDTM and ADaM)
• You Bring expertise in handling and analyzing different types of data (multi-modal)
• You have demonstrated ability to deliver programming outputs independently
• You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
• You are fluent in English

Preferred:

• Possess attention to detail for regulatory submission processes and related documentation
• Demonstrate critical thinking, strong organizational and problem-solving skills
• Experience working in cross-functional global study teams
• Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences
• Experience with multiple phases of drug development (early and/or late stage)
• Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders
• Demonstrated willingness to adapt, grow, and evolve in response to shifting priorities

Location

This position is based in Basel Relocation Assistance is not available.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.