Principal Statistical Programmer in Cambridge, Nova Scotia at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistical Programmer based in Canada.

This is a senior-level role within a global clinical research environment focused on delivering high-quality statistical programming support for clinical trials.
You will take ownership of complex projects spanning SDTM and ADaM dataset development, ensuring accuracy, compliance, and regulatory readiness.
The role involves close collaboration with cross-functional teams including biostatistics, data management, and clinical operations.
You will also contribute to the development and validation of statistical outputs supporting clinical study reports and regulatory submissions.
In addition to technical leadership, you will mentor junior programmers and help strengthen programming standards and best practices.
The environment is dynamic, quality-driven, and client-focused, offering exposure to innovative therapies and global regulatory frameworks.

• Lead complex statistical programming projects, ensuring high-quality, on-time delivery of SDTM and ADaM datasets and related deliverables.
• Develop, validate, and review dataset specifications, outputs, define.xml files, and tables of contents in alignment with CDISC standards and SOPs.
• Perform quality control checks, including Pinnacle 21 validation reviews, data integrity assessments, and consistency checks for TLGs.
• Support regulatory submission activities and may interact with clients and regulatory agencies on assigned projects when required.
• Provide technical leadership, mentorship, and training to junior statistical programmers and contribute to internal programming standards.
• Develop, maintain, and enhance macros, utilities, and programming tools to improve efficiency and data quality.
• Ensure proper documentation, QC, and archiving of all programming deliverables in compliance with corporate and study-specific guidelines.

• Master’s or PhD in Statistics, Biostatistics, Epidemiology, Computer Science, or related field with at least 8 years of clinical trial statistical programming experience, OR
• Bachelor’s degree in a relevant field with at least 10 years of experience in clinical trial statistical programming.
• Strong expertise in CDISC standards, including SDTM and ADaM dataset development and validation.
• Solid experience supporting regulatory submissions in a clinical research or CRO environment.
• Proficiency in statistical programming tools and languages commonly used in clinical trials (e.g., SAS).
• Strong analytical, problem-solving, and quality control skills with attention to detail.
• Excellent communication skills with the ability to collaborate across technical and non-technical teams.
• Proven ability to lead projects, mentor others, and manage multiple priorities in a fast-paced environment.

• Comprehensive medical, dental, and vision insurance coverage
• Life, AD&D, and disability insurance (short- and long-term)
• Pension plan and retirement benefits
• Generous paid time off and sick leave
• Tuition reimbursement and professional development support
• Fitness and wellness reimbursement programs
• Employee Assistance Program (EAP) for personal and professional support
• Performance-based bonus opportunity