Senior Statistical Programmer
- Canada
Full-time
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Job details
- Job type
- Full-time
- Experience
- 6+ years of clinical trial statistical programming experience with a Masters Degree or higher in a Statistical related subject.
- Posting language
- English
- Posted
Original job description
Senior/Principal Statistical Programmer | Small CRO | Remote/Hybrid
We're partnered with a small CRO who are experiencing a large amount of growth within Biometrics.
The Role: As a Senior Statistical Programmer, you'll lead high-impact projects, tackling complex statistical programming tasks and managing project timelines. You'll work directly with clients and regulatory agencies, ensuring data quality and delivering programming solutions for clinical trials. You’ll also have the chance to mentor junior team members, contribute to regulatory submissions, and develop new programming tools.
Key Responsibilities:
- Lead statistical programming for complex projects, solving intricate challenges while ensuring project delivery meets quality standards.
- Collaborate with clients, providing programming oversight, project estimates, and participating in bid defenses.
- Contribute to regulatory submissions and represent the company in regulatory discussions.
- Create and validate SDTM and ADaM dataset specifications, ensuring adherence to SOPs.
- Program and validate datasets, ensuring accuracy and data integrity.
- Mentor junior programmers and lead project teams, fostering development and collaboration.
- Innovate by developing macros, utilities, and tools to enhance efficiency.
- Implement data integrity checks, ensuring scientific accuracy and quality.
Qualifications:
- Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science.
- 6+ years of clinical trial statistical programming experience with a Masters Degree or higher in a Statistical related subject.
- Experience working with clinical trial data, SDTM/ADaM datasets, and regulatory submissions.
What to do next?
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More about this job
Responsibilities
Lead statistical programming for complex clinical trial projects, including creating and validating SDTM and ADaM specifications and datasets while ensuring quality and data integrity. Collaborate with clients and regulatory agencies, contribute to submissions, manage project delivery, mentor junior programmers, and develop tools to improve efficiency.
Requirements
Requires a master’s degree or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science, along with at least six years of clinical trial statistical programming experience. Candidates should have experience with clinical trial data, SDTM and ADaM datasets, and regulatory submissions.
Skills
- Statistical Programming
- Clinical Trial Programming
- SDTM
- ADaM
- Dataset Specification
- Dataset Programming
- Dataset Validation
- Regulatory Submissions
- Data Integrity
- Quality Assurance
- Project Management
- Client Collaboration
- Project Estimation
- Team Leadership
- Mentoring
- Macro Development
Visa sponsorship
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Categories
- Healthcare
- Science & Research
- Data & Analytics
- Management & Leadership
Keywords
- Biometrics
- Clinical Trials
- Statistical Programming
- SDTM
- ADaM
- Dataset Specifications
- Dataset Validation
- Regulatory Submissions
- Regulatory Agencies
- Regulatory Discussions
- Clinical Trial Data
- Data Quality
- Data Integrity
- Scientific Accuracy
- Standard Operating Procedures
- Project Management
- Project Estimates
- Bid Defenses
- Client Collaboration
- Team Leadership
- Mentoring
- Macro Development
- Programming Utilities
- Programming Tools
- Statistics
- Biostatistics
- Epidemiology
- Computer Science
- CRO