What are the responsibilities and job description for the Senior Statistical Programmer position at Jobgether?
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Statistical Programmer in Canada.
In this role, you will play a critical part in supporting clinical trials by leading statistical programming activities across multiple studies within a regulated clinical research environment. You will be responsible for the development and validation of SDTM and ADaM datasets, statistical outputs, and submission-ready deliverables used in clinical study reporting and regulatory submissions. Working closely with biostatistics, data management, and cross-functional teams, you will ensure high-quality, compliant, and timely outputs aligned with global standards. This position requires strong technical expertise in SAS programming, CDISC standards, and clinical data structures. You will also contribute to process improvements, standardization initiatives, and efficiency enhancements across programming workflows. This is a highly collaborative and detail-driven role where your work directly supports data integrity and regulatory success in clinical development programs.
\n- Lead statistical programming activities across one or multiple clinical trials, ensuring high-quality delivery of datasets, tables, listings, figures, and submission packages.
- Develop, maintain, and validate annotated Case Report Forms (aCRFs), SDTM and ADaM datasets, and derived datasets in accordance with CDISC standards and study requirements.
- Program and validate statistical outputs (TLFs) and support deliverables for DMC meetings, interim analyses, and clinical study reports.
- Review and provide input on statistical analysis plans, TLF shells, and data management documentation, including eCRFs and edit checks.
- Support data management activities by identifying, tracking, and resolving data issues in collaboration with biostatistics and programming teams.
- Validate datasets and define.xml files using tools such as Pinnacle 21 and ensure compliance with regulatory and industry standards.
- Contribute to the development and use of global SAS macros to improve efficiency and consistency in programming deliverables.
- Act as a lead statistical programmer for assigned studies, including oversight of scope, timelines, and budget alignment.
- Participate in internal initiatives to improve programming standards, automation, and process efficiency.
- Stay current with regulatory guidelines, CDISC standards, and industry best practices, and may mentor junior programmers.
Requirements
- Bachelor’s degree in Statistics, Computer Science, or a related field; Master’s degree is an asset.
- Minimum 5 years of clinical research experience in CRO, pharmaceutical, or biotech environments, including at least 4 years in statistical programming and 1 year in a lead role.
- Strong expertise in SAS programming; SAS certification is an asset.
- Solid knowledge of CDISC standards (SDTM, ADaM, Define.xml) and regulatory submission requirements.
- Good understanding of clinical trial processes, ICH guidelines, and regulatory frameworks (Health Canada, FDA).
- Experience working with SAPs, TLF shells, and clinical data specifications.
- Knowledge of XML programming is an asset.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Excellent attention to detail and strong analytical thinking.
- Ability to work independently while also collaborating effectively within cross-functional teams.
- Strong communication skills in English; French is an asset.
Benefits
- Permanent full-time remote position based in Canada
- Flexible work schedule supporting work-life balance
- Opportunity to work in a specialized clinical research organization focused on dermatology and innovation
- Exposure to global clinical trials and regulatory submission projects
- Continuous learning and professional development opportunities
- Collaborative and supportive work culture emphasizing innovation and reliability
- Participation in process improvement and standardization initiatives
- Career growth opportunities within an expanding international organization
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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