Drive impactful electronic submissions as a DSX eSub/COE Specialist at Roche in Mississauga. Engage in statistical programming to enhance regulatory compliance and efficiency. In this pivotal role within the Statistical Programming Enablement team, your expertise will facilitate the development of SDTM and ADaM datasets.
You will be responsible for ensuring that global regulatory submissions are scientifically sound and fully compliant with evolving directives. Your proactive approach will foster collaboration with regulatory and clinical teams, enhancing the submission process's scalability. Key Responsibilities:
- Develop and validate SDTM and ADaM datasets
- Ensure submission packages are compliant and complete
- Monitor evolving regulatory guidelines for submissions
- Implement quality control and workflow optimization
- Innovate tools and templates for scalable submission processes Requirements:
- Bachelor’s or Master’s in a relevant field
- 1-3 years of statistical programming experience
- Familiarity with SAS, R, or Python
- Solid attention to details and workflow optimization skills
- Effective verbal and written communication abilities Leverage your programming expertise to support Roche’s global regulatory submission efforts and make a difference in healthcare.