Senior Statistical Programmer I

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Employer: Everest Clinical Research Corporation

Business Address: 675 Cochrane Drive, East Tower, 4th Floor, Markham Ontario, L3R 0B8 and remote work permitted from home within the Greater Toronto Area.

Position: Senior Statistical Programmer I

Vacancies: One (1)

Terms of Employment: Full-time / Permanent

Location: Markham, Ontario

Hours of Work: 37.5 hours/week

Language: English

Benefits: Eligible for discretionary bonuses and/or salary increases in accordance with company policy. Eligible for medical, dental, vision, extended health benefits, pension, fitness subsidy, life insurance, as well as paid vacation, sick days, and floater days

Salary: $120,000 - $130,000 CAD per annum

Contact: Please send resumes to by mail to 675 Cochrane Drive, East Tower, 4th Floor, Markham, Ontario L3R 0B8 (1-905-752-5222) or by email to [email protected] and include “Senior Statistical Programmer I” in the email subject line.

Duties:

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work.
• Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others.
• Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
• Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists.
• Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
• Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
• Participate and/or lead programming teams in support of product regulatory submission related activities.
• Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities.
• Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
• Complete job-required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.
• Document data and programming information in accordance with corporate SOPs and guidelines.
• Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
  
  

Requirements:

• Master’s degree in statistics, biostatistics, epidemiology, bioinformatics, mathematic, or computer sciences.
• 4+ years of experience in clinical trial statistical programming and/or data analysis.
• Advanced level proficiency in SAS.
• Demonstrated strong capabilities and/or sustained high level of performance as a Statistical Programmer.
• Experience with the following is required:.
• Microsoft Word, Excel, PowerPoint, Outlook, Project.
• Must be action oriented, have composure, be creative, be customer focused, have functional and technical skills, able to learn on the fly, able to persevere, excellent planning, organizational, time management and problem -solving skills, able to prioritize, and able to pick up on new technical skills quickly.
  

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodation for candidates participating in any part of our recruitment and selection process.