At this time MaxSys Staffing & Consulting will not sponsor individuals for employment visas. Only Candidates authorized to work in Canada will be contacted.
Position Overview:
The Clinical Data Analyst is responsible for most aspects of data analytics activities in support of assigned clinical studies. Ensures that quality of services meets internal and external customer requirements.
Working under minimal supervision, is responsible for most aspects of data analytics activities in support of assigned clinical studies. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercise’s judgment in planning, organizing, and performing work; monitors performance and reports status within area of responsibility. Ensures that quality of services meets internal and external customer requirements.
Responsibilities:
- Generate and validate tables, listings, and figures (TLF) based on specifications provided by Statistics and/or Clinical Writers.
- With minimal manager oversight, performs all data analytics activities for assigned studies.
- Ensures that all data analytics activities for assigned studies are completed on time and with high quality or escalates as appropriate.
- May support EDC development and visualization tools (PowerBI).
- Communicates well with peers, study teams and management as appropriate to support studies and goals.
- Represents the Data Analytics group at study team meetings.
- Applies best practices and established standards.
- Has a general understanding of the clinical trial process and regulations that apply.
- Follows departmental Standard Operating Procedures (SOPs), and guidelines.
- Trains and mentor’s junior staff.
- Additional study specific activities.
Requirements:
- Minimum 3 years in a programming role.
- Bachelor’s Degree (Data Science, Computer Science, Statistics, Bioinformatics or related discipline)
- Independently Develop SAS/R programs to generate and validate statistical output reports of trial data based on the SAP and TLFs mock-up shells
- Experience generating outputs for regulatory submissions (FDA, Health Canada)
- Programming experience in R, SQL, JSON
- Provide statistical programming support to Clinical Study Reports, data analysis and reporting
- Develop SAS/R programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews
- Experience with CDISC and SDTM implementation desirable
- Support development of technical programming specifications for SDTM, ADS or ADaM standards.
- Knowledge of EDC development and visualization tools (PowerBI, Tableau) is an asset.
If you are interested in this position, please apply.
Only qualified candidates may be contacted about this role.
MaxSys is committed to a diverse, equal, and inclusive workforce. We are committed to meeting the needs of persons with disabilities. If you need to be accommodated during any phase of the hiring process, please advise our Recruitment team and we will make all reasonable efforts to accommodate your request.
At this time MaxSys Staffing & Consulting will not sponsor individuals for employment visas. Only Candidates authorized to work in Canada will be contacted.
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Job Types: Full-time, Fixed term contract
Pay: $66,000.00-$79,000.00 per year
Schedule:
Education:
- Bachelor's Degree (required)
Experience:
- Programming: 3 years (required)
- SAP: 1 year (preferred)
- SAS/R Programs: 1 year (preferred)
Work Location: In person