We are seeking experienced Senior Statistical Programmers to support a variety of clinical research projects across pharmaceutical, biotechnology, and medical device industries. The successful candidate will bring expertise in statistical programming, project leadership, and regulatory submission support to deliver high-quality data outputs in compliance with industry standards
Location: Remote (Canada) or On-site (Greater Toronto Area)
Roles and Responsibilities
Lead statistical programming activities for assigned projects, ensuring high-quality deliverables and timely completion.
Develop SDTM and ADaM dataset specifications and perform quality control (QC) reviews.
Program and validate SDTM and ADaM datasets in accordance with project requirements and CDISC standards.
Conduct Pinnacle 21 validation checks and resolve compliance issues.
Create and QC define.xml files and related documentation.
Review and ensure overall quality and consistency of statistical tables, listings, and figures (TLFs).
Support regulatory submission activities through programming leadership and technical expertise.
Contribute to the development, maintenance, and improvement of macros, utilities, and processes for efficiency and consistency.
Ensure proper documentation and archival of datasets, programming information, and project deliverables.
Provide mentorship, guidance, and oversight to programming team members as required.
Qualifications and Skills
At least 6 years’ experience in clinical trial statistical programming
Proficiency in SAS programming familiarity with CDISC standards (SDTM, ADaM).
Experience supporting regulatory submissions (FDA, EMA, Health Canada) strongly preferred.
Strong project management skills with the ability to lead programming activities and collaborate effectively with cross-functional teams.
Excellent problem-solving, communication, and organizational skills.
Education
Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, Mathematics, or related field
Benefits
Fully remote flexibility across Canada (with option for on-site in GTA).
Generous paid time off (PTO) including vacation, sick days, and personal days.
Company-wide holiday shutdown between Christmas and New Year’s.
Annual performance bonus.
Comprehensive benefits package including health, dental, vision, and retirement savings plan.
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