Principal Statistical Programmer
Markham, Ontario, Canada; Remote, Canada
R
CAD 125K-175K Senior-level Full Time
Tasks
- Archive clinical trial data and programming information
- Create define.xml files
- Create table of contents
- Develop ADaM specifications
- Develop SDTM specifications
- Document data and programming information
- Generate review and resolve Pinnacle 21 validation issues
- Lead complex statistical programming projects
- Maintain and develop macros and utilities
- Manage project delivery with quality
- Participate and lead programming teams for regulatory submissions
- Perform QC checks using work instruction checklists
- Perform QC review of dataset specifications
- Perform data integrity checks with QC and validation
- Perform quality consistency review of statistical TLGs
- Perform quality review of regulatory submission documents datasets and programs
- Program and validate ADaM datasets
- Program and validate SDTM datasets
- Represent company in client programming discussions
- Represent company to regulatory agencies
- Resolve complex statistical programming issues
- Review QC of define.xml files
- Run CDISC standard compliance checks
- Train mentor and provide technical guidance
Perks/Benefits
- Accidental death and dismemberment insurance
- Dental insurance
- Employee assistance program
- Fitness reimbursement
- Life insurance
- Long-term disability
- Medical insurance
- Paid time off
- Pension plan
- Performance-based bonus
- Short-term disability
- Sick leave
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
ADaM | CDISC | CDISC Compliance Checks | Clinical data | Clinical data standards | Compliance checks | Data Integrity | Data Standards | Dataset Specifications | Define.xml | Pinnacle 21 | Programming macros | Quality Control | Regulatory Submissions | SDTM | Utilities | Validation
Education
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