DSX eSub/COE Specialist

Roche • Mississauga, ON

2d

About The Position

The DSX eSub/COE Specialist is a key individual contributor within the Statistical Programming Enablement team, responsible for developing strategy and delivering global electronic regulatory submissions across multiple studies or programs within the Analytical Data Science function. As the primary owner of electronic submission programming workflows and tools, this role ensures compliance with evolving regulatory requirements while driving consistency, efficiency, and inspection readiness. This role is expected to remain up-to-date on new Health Authority requirements that impact data submission expectations and / or advance future submissions process. This role will serve as a subject matter expert within the Submission, Fillings and FAIR Center of Excellence, who partners cross-functionally with Regulatory, Biostatistics, and Clinical teams to align submission strategies, mentor supporting programmers, and advance scalable, high-quality programming solutions that enable successful global submissions. You support the development of tools and processes for electronic regulatory submission programming, including the development, validation, and delivery of SDTM and ADaM datasets, as well as submission-ready outputs (define.xml, annotated CRFs, reviewer’s guides, and other deliverables) to meet global regulatory requirements You assist programming efforts for studies or programs, ensuring completeness, consistency, and traceability of submission packages across multiple molecules or indications You interpret and implement evolving regulatory guidelines (e.g., FDA, PMDA, EMA) to ensure electronic submission packages are compliant, scientifically sound, and inspection-ready You optimize submission programming workflows, including automation, reuse of components, and quality control approaches, to drive operational efficiency and inspection readiness You collaborate cross-functionally with regulatory, clinical, biostatistics, data management, and data standards teams to align timelines, standards, and submission strategy across functions You contribute to innovation and capability building in submission programming, including development of tools, templates, and training to enhance scalability and robustness of eSubmission processes You proactively identify risks and escalate challenges, contributing to resolution strategies and ensuring timely submission deliverables

Requirements

• Bachelor's or Master's degree in Computer Science, Statistics, Bioinformatics, Data Science, or a related field
• Typically 1-3 years of experience in statistical programming, with an interest in or exposure to supporting regulatory submissions
• Foundational knowledge of programming languages such as SAS, R, or Python, and version control tools like Git
• Basic understanding of statistical quality, endpoints, and QC processes
• Strong attention to detail and commitment to quality, with a growth mindset and openness to feedback
• Capacity for independent thinking and ability to make decisions based upon sound principles
• Excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
• Respect for cultural differences when interacting with colleagues in the global workplace
• Excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language

Nice To Haves

• Exposure to CDISC standards or regulatory programming deliverables
• Ability to follow technical documentation and contribute to team processes
• Interest in workflow optimization and continuous improvement

Responsibilities

• Support the development of tools and processes for electronic regulatory submission programming, including the development, validation, and delivery of SDTM and ADaM datasets, as well as submission-ready outputs (define.xml, annotated CRFs, reviewer’s guides, and other deliverables) to meet global regulatory requirements
• Assist programming efforts for studies or programs, ensuring completeness, consistency, and traceability of submission packages across multiple molecules or indications
• Interpret and implement evolving regulatory guidelines (e.g., FDA, PMDA, EMA) to ensure electronic submission packages are compliant, scientifically sound, and inspection-ready
• Optimize submission programming workflows, including automation, reuse of components, and quality control approaches, to drive operational efficiency and inspection readiness
• Collaborate cross-functionally with regulatory, clinical, biostatistics, data management, and data standards teams to align timelines, standards, and submission strategy across functions
• Contribute to innovation and capability building in submission programming, including development of tools, templates, and training to enhance scalability and robustness of eSubmission processes
• Proactively identify risks and escalate challenges, contributing to resolution strategies and ensuring timely submission deliverables

Benefits

• Relocation benefits are not available for this job posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees