Clinical Statistical Programmer Jobs in Ontario (NOW HIRING)

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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 Senior 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 5+ years of solid experience in statistical programming in a clinical development setting, or an advanced degree with 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

Relocation Benefits are not available for this job posting.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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