What are the responsibilities and job description for the Senior Statistical Programmer position 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 Senior Statistical Programmer based in Canada.
This is a senior clinical research opportunity for a statistical programming professional supporting complex clinical trial and regulatory activities. You will lead statistical programming work across SDTM and ADaM datasets, ensuring high-quality, compliant, and timely deliverables. The role combines hands-on programming, validation, quality control, project leadership, and collaboration with internal and external stakeholders. You will contribute to Clinical Study Reports, Integrated Summaries of Safety and Efficacy, and regulatory submission activities. Strong knowledge of CDISC standards, Pinnacle 21 validation, define.xml, and clinical data integrity will be central to your success. You will also help improve programming efficiency through reusable macros, utilities, and robust quality processes. The position offers the flexibility to work remotely from anywhere in Canada or from an on-site location in Toronto/Markham, Ontario.
\n- Statistical Programming Leadership: Lead day-to-day statistical programming activities, resolve technical and project-related issues, maintain high-quality deliverables, and identify opportunities to improve programming efficiency and productivity.
- Project Delivery: Lead assigned projects by applying project management skills and advanced statistical programming techniques to deliver high-quality outputs on schedule while maintaining strong client relationships.
- SDTM and ADaM Specifications: Develop and review SDTM and ADaM dataset specifications for Clinical Study Reports (CSRs), Integrated Summaries of Safety (ISS), and Integrated Summaries of Efficacy (ISE), following applicable SOPs and project-specific requirements.
- Dataset Programming and Validation: Program and validate SDTM and ADaM datasets according to approved specifications, ensuring accuracy, consistency, and compliance with project standards.
- CDISC Compliance: Perform CDISC-compliant checks on SDTM and ADaM datasets, generate and review Pinnacle 21 validation results, resolve identified issues, and complete additional QC activities using established checklists.
- Statistical Outputs: Conduct comprehensive quality and consistency reviews of statistical tables, listings, and graphs (TLGs) before delivery to internal teams or clients.
- Define.xml Development: Create SDTM and ADaM define.xml files and perform quality control reviews of files prepared by other programmers.
- Regulatory Submission Support: Participate in or lead statistical programming teams supporting product regulatory submission activities, ensuring deliverables meet required quality and compliance standards.
- Programming Utilities: Maintain expertise in existing statistical programming macros and utilities while developing new tools that improve productivity, standardization, and efficiency.
- Data Integrity and Surveillance: Program and validate complex data integrity checks to support data quality and ongoing scientific data surveillance throughout clinical studies.
- Documentation and Compliance: Complete required and project-specific training, follow applicable corporate and sponsor policies, SOPs, and work instructions, and maintain accurate programming and data documentation.
- Clinical Data Archiving: Archive SDTM and ADaM datasets, programs, and related programming information in accordance with established clinical trial archival procedures.
Requirements
- Education and Experience: Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, Computer Science, or a related field, combined with at least 4 years of clinical trial statistical programming experience; alternatively, a Bachelor’s degree in one of these fields with at least 6 years of relevant experience.
- Clinical Trial Programming: Strong professional experience in statistical programming within the clinical research or pharmaceutical industry, with the ability to independently manage complex programming deliverables.
- SDTM and ADaM: Demonstrated expertise developing, programming, validating, and performing QC of SDTM and ADaM datasets for clinical study and regulatory deliverables.
- CDISC Standards: Strong knowledge of CDISC standards and experience performing compliance checks and resolving validation findings using Pinnacle 21.
- Regulatory Submissions: Experience supporting or leading statistical programming activities associated with regulatory submissions is highly valuable.
- Define.xml: Hands-on experience creating and reviewing SDTM and ADaM define.xml files.
- Quality Control: Strong understanding of programming validation, QC methodologies, data integrity checks, consistency reviews, and documentation practices within regulated clinical research environments.
- Programming Tools: Ability to work effectively with statistical programming macros, utilities, and related tools, with an interest in developing solutions that improve programming efficiency.
- Project Leadership: Strong organizational and project management capabilities, including the ability to prioritize deliverables, resolve issues, manage timelines, and coordinate programming activities.
- Analytical Skills: Excellent analytical and problem-solving abilities, with strong attention to detail and a commitment to scientific and data quality.
- Communication: Strong written and verbal communication skills, with the ability to collaborate effectively with internal teams, clients, sponsors, and cross-functional stakeholders.
- Compliance Mindset: Ability to consistently follow applicable SOPs, work instructions, sponsor requirements, and clinical research standards while maintaining accurate documentation and archival records.
Benefits
- Competitive Compensation: Estimated annual salary range of CAD $90,000–$140,000.
- Remote Flexibility: Opportunity to work remotely from a home-based office anywhere in Canada in accordance with the applicable work-from-home policy.
- On-Site Option: Position also available at the Toronto/Markham, Ontario location.
- Health Coverage: Medical, dental, and vision benefits to support employees and their families.
- Insurance Protection: Life and AD&D insurance, along with short- and long-term disability coverage.
- Retirement Benefits: Pension plan designed to support long-term financial well-being.
- Paid Time Off: Generous paid time off and sick leave.
- Performance Bonus: Opportunity to earn a performance-based bonus.
- Education Support: Tuition reimbursement to support continued learning and professional development.
- Fitness Support: Fitness reimbursement to encourage health and wellness.
- Employee Assistance: Employee Assistance Program (EAP) providing additional personal and well-being support.
- Professional Growth: Opportunity to work on sophisticated clinical research and regulatory programming activities while developing expertise across statistical programming, data standards, and clinical trial deliverables.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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