Roche
DSX eSub/COE Specialist
Mississauga
Sponsorship not specifiedDetected 8 days ago
PythonGitData ScienceStatisticsFDA RegulatoryBioinformaticsSASLeadershipCommunicationProblem SolvingCritical ThinkingBiostatistics
About the role
- 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.
- 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.
Responsibilities
- PDD Analytical Data Science teams are mobilized across the portfolio to generate data-driven insights, identify opportunities for scale, and implement impactful solutions.
- 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
Requirements
- You hold a Bachelor's or Master's degree in Computer Science, Statistics, Bioinformatics, Data Science, or a related field
- You have typically 1-3 years of experience in statistical programming, with an interest in or exposure to supporting regulatory submissions
- You have foundational knowledge of programming languages such as SAS, R, or Python, and version control tools like Git
- You have a basic understanding of statistical quality, endpoints, and QC processes
- You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
- You have 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 have
- 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
- Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
- 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.
- Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
- Roche is an Equal Opportunity Employer.
Compensation
- The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range.
Benefits
- 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.
Company info
- 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.
- 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.
- 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.
- 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.
This listing is sourced directly from Roche's careers page and normalized into a canonical job model.