Statistical Programmer
- Canada
Full-time
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Job details
- Job type
- Full-time
- Experience
- Minimum 6 years’ experience as a statistical programming working on clinical trials.
- Posting language
- English
- Posted
Original job description
****Must be able to work W2 (NO 3RD PARTIES!!!!) in the US and/or Canada
Required skills:
- Minimum 6 years’ experience as a statistical programming working on clinical trials.
- Must have had Direct Reports in your career
- Recent Oncology experience needed
- Good knowledge of TFL programming.
- Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
- Attention to details.
- Excellent communication skills.
- A bachelor’s degree in either statistics , computer or life science discipline
Duties will include:
- Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
- Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
- Train, mentor and share knowledge with the rest of the statistical programming team.
- Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
- Might include Interaction with customers on a project or program level.
- Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
- Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
- Development of SAS programs for study TFLs, based on study SAP and shells.
- Review and verify all types of conversions and programming done based on customer requirements.
- Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
- Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.
More about this job
Responsibilities
Develop and validate SAS programs for clinical data conversions, SDTM and ADaM datasets, and study tables, figures, and listings (TFLs), following CDISC or customer requirements. Support submission preparation, project management, programming standards, and team development through mentoring, training, and collaboration with customers.
Requirements
Requires at least six years of statistical programming experience in clinical trials, recent oncology experience, and prior experience managing direct reports. Candidates need knowledge of TFL programming, CDISC SDTM and ADaM, submission documentation, and a bachelor's degree in statistics, computer science, or a life science discipline.
Skills
- Statistical Programming
- Clinical Trials
- Oncology
- TFL Programming
- CDISC Standards
- SDTM
- ADaM
- SAS
- Clinical Data Conversion
- Analysis Datasets
- Submission Documentation
- Project Management
- Team Leadership
- Mentoring
- Communication
- Attention to Detail
Visa sponsorship
Not detected in the job text
Categories
- Data & Analytics
- Science & Research
- Healthcare
- Management & Leadership
- Technology
Keywords
- Statistical Programming
- Clinical Trials
- Oncology
- SAS
- CDISC
- SDTM
- ADaM
- TFL
- Tables, Figures, And Listings
- Clinical Data
- Data Conversion
- Analysis Datasets
- Reviewer’s Guide
- Define.xml
- Clinical Data Submission
- Statistical Analysis Plan
- Programming Specifications
- Validation
- Standard Operating Procedures
- Project Management
- Timelines
- Scope Management
- Budget Management
- Resource Planning
- Direct Reports
- Team Mentoring
- Customer Interaction
- Best Practices
- Implementation Guides
- Biotechnology