Senior Statistical Programmer
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Statistical Programmer based in Canada.
This role offers the opportunity to contribute to high-impact clinical research supporting the development of innovative pharmaceuticals, biologics, and medical devices.
You will play a key part in delivering high-quality statistical programming outputs across clinical trial phases and regulatory submissions.
The position involves close collaboration with cross-functional teams in a dynamic, fast-paced, and quality-driven environment.
You will work on complex datasets, ensuring compliance with CDISC standards and global regulatory requirements.
This is an opportunity to take ownership of technical deliverables while contributing to the success of global clinical studies.
The role is ideal for professionals who thrive in a detail-oriented, science-driven setting with strong expectations for accuracy and efficiency.
Accountabilities:
- Lead and resolve day-to-day statistical programming issues while ensuring high-quality, timely deliverables and continuous process improvements in efficiency and productivity.
- Oversee assigned study activities by applying project management and advanced statistical programming expertise to ensure on-time, high-quality outputs and strong client confidence.
- Develop, program, and validate SDTM and ADaM datasets for CSRs, ISS, and ISE in alignment with SOPs, study specifications, and regulatory standards.
- Conduct QC and validation of datasets, specifications, TLFs, and define.xml files, including CDISC compliance checks and resolution of Pinnacle 21 issues.
- Perform quality and consistency reviews of statistical tables, listings, and figures prior to internal or client delivery.
- Support regulatory submissions and contribute to programming team activities, ensuring compliance with all applicable policies and guidelines.
- Develop, maintain, and enhance programming macros and utilities while performing advanced data integrity and quality checks.
- Ensure proper documentation, archiving, and training compliance in accordance with corporate and study-specific requirements.
- Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, Computer Science, or related field with at least 4 years of clinical trial statistical programming experience.
- OR Bachelor’s degree in a relevant field with at least 6 years of clinical trial statistical programming experience.
- Strong expertise in SDTM and ADaM dataset development, CDISC standards, and regulatory submission requirements.
- Hands-on experience with statistical programming languages commonly used in clinical research environments.
- Solid understanding of Pinnacle 21 validation tools, data quality checks, and regulatory expectations.
- Ability to manage multiple priorities in a deadline-driven environment while maintaining high attention to detail.
- Strong communication skills and ability to collaborate effectively with cross-functional and global teams.
- Proactive mindset with strong problem-solving skills and the ability to work independently or in team settings.
- Competitive salary range of $90,000 – $140,000 CAD.
- Comprehensive health coverage including medical, dental, and vision plans.
- Life, accidental death, and disability insurance coverage.
- Pension plan and performance-based bonus opportunities.
- Tuition reimbursement and professional development support.
- Fitness reimbursement and employee assistance program (EAP).
- Generous paid time off, including vacation and sick leave.
- Flexible work arrangements, including remote work options within Canada.