Princeps Technologies Inc, IT consulting firm headquartered at 1 University Ave, Toronto, Ontario, Canada M5J 2P1, is seeking to fill in a permanent full-time position of an applied statistician.
A successful candidate must have:
• Bachelor’s or Master’s degree in Computer Science, Statistics, Biotechnologies or related health science field
• at least 2 years of proven experience with Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, Efficacy analysis, SAS and SQL programming tools and other programming languages used and processes within the CRO, biostatistics, and Medical/ Pharmaceutical industry; able to work with Minitab and R programing languages
• Excellent English language skills, language of work
• Ability to work independently, excellent organizational skills
The duties of this position are as follows:
- Initiate project start-up activities, Example Unix/Windows project area set-up, creation of global programs (e.g. setup.sas, formats.sas, utility macros), tracking spreadsheets and other project required documentation for each project;
- Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy data) to the team members, statisticians and trial sponsors;
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and impact of these on the project
- Develop SDTM (Study Data Tabulation Model) mapping documents like CRF annotation, Mapping specifications, Programming SDTM datasets, Programming SDTM validation programs (using sas programming), Create ADaM (Analysis Dataset Model) Specifications, ADaM dataset programming and validation programs for ADaM datasets (using sas programming, CDISC: Clinical Data Interchange Standard’s Consortium guidelines)
- Review ADaM specification documents and ensure the specifications meet the analysis criteria specified in the Statistical Analysis Plan (SAP);
- Assist in the production and quality control of analysis plans, produce and quality check of Tables Listings and Figure mock-shells (templates);
- Produce Quality Check derived datasets, tables, figures and data listings as required;
- Create standard SAS macros and applications to improve the efficiency of the statistical programs and outputs;
- Ability to work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required;
Work location is at 1 University Ave, Toronto, Ontario, Canada M5J 2P1 and across GTA area.
The compensation package consists of a salary of $42 per hour with minimum of 40 work hours per week workload less applicable statutory deductions.
Please apply by sending your resume to Tatiana@lawpoint.ca