Job Description
Job Title: Senior Statistical Programmer
Location: Ontario, Canada
Employment Type: Indefinite
Function: Service Delivery
Role Overview
The Senior Statistical Programmer is a senior contributor within the Service Delivery team, responsible for delivering high-quality clinical programming outputs across a portfolio of studies. This role requires advanced expertise in SAS programming, CDISC standards, and clinical data management practices, with the ability to independently manage concurrent activities and collaborate effectively across departments.
Primary Responsibilities
Clinical Programming & Data Delivery
- Create and validate edit check programs using standard validation practices.
- Develop SAS programs to convert data from EDC to protocol-specific SAS datasets.
- Review and annotate CRFs for SDTM mapping.
- Provide statistical programming support to generate ADaM datasets, tables, listings, and figures for individual studies (both safety and efficacy) and ISS/ISE studies.
- Apply advanced knowledge of CDISC standards (SDTM and ADaM) across all deliverables.
- Run P21 reports for both SDTM and ADaM datasets and interpret the results.
- Develop and validate SAS macros and format libraries.
- Ensure the quality of client data and data exports.
- Create documentation related to the generation of customer-specific SAS datasets.
- Maintain the SAS environment, including assistance with installation, updates, and maintenance.
CDM & Regulatory Standards
- Review and approve User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents.
- Develop and implement new CDM systems and enhancements to current CDM systems.
- Understand, create, and communicate information about creating CDISC-compliant datasets.
- Assist the Study Quality Representative in testing protocol-specific SAS conversion programs.
Project & Timeline Management
- Proactively manage concurrent activities within a study or project.
- Assess and assign target dates for project timelines in collaboration with the manager.
- Adhere to project target dates and communicate any changes to appropriate personnel, including the Project Manager.
- Communicate and escalate risks within assigned studies or projects.
- Keep the department head informed of current issues.
Efficiency & Quality Improvement
- Coordinate activities of the Clinical Programming department with related departments (Operations Programming, Study QA, PM, and DM) to ensure efficiency.
- Evaluate current procedures and work instructions to develop and implement improvements.
- Assist the training department with the development and maintenance of Clinical Programming training materials.
Secondary Responsibilities
- Explore new opportunities to add value to organizational and departmental processes.
- Support team members in achieving results and perform other duties as assigned.
- Attend and participate in applicable company-sponsored training.
- Read, understand, and adhere to organizational Standard Operating Procedures (SOPs).
- Assist in establishing and enforcing departmental standards.
- Review and provide recommendations to management on operational procedures and process improvement initiatives.
Skills & Competencies
- Ability to work effectively in both group and independent settings; adaptable to changing priorities.
- Excellent attention to detail and a meticulous approach to work.
- Strong interpersonal and communication skills, both verbal and written.
- Strong documentation and organizational skills.
- Professional, positive, and collaborative attitude.
Education & Experience
- Bachelor's degree in Computer Science, Statistics, or a related field - required.
- Educational background in human-computer interaction, informatics, cognitive science, applied psychology, or related applied science fields is a plus.
- 8+ years of SAS programming experience in a pharmaceutical or clinical research industry environment - required.
- 5+ years of experience working with CDISC standards, SQL, and relational databases - required.
- 3+ years of experience with database organization and data extraction for listings and reports - required.
Work Commitments
- Standard hours: 40 hours per week, Monday through Friday, with a one-hour lunch break. Additional hours may be required as needed.
- Willingness to work in shifts as and when required.
- Hybrid 3x per week in-office requirements. 2x per week remote-based obligations
Compensation & Benefits
Sitero proudly offers a competitive compensation package including a competitive base salary, paid time off, and comprehensive healthcare and retirement benefits.
