Statistical Programmer

This is a fully remote position, open to applicants in Canada.

📋 Description

• Create, sustain, and verify annotated Case Report Forms (aCRFs)

• Design, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets, or derived datasets, along with Tables, Listings, and Figures (TLFs)

• Generate deliverables for Data Monitoring Committee data review meetings, Interim Analyses, and Clinical Study Reports

• Assist Data Management with data cleaning tasks through programming, reporting, reviewing, and resolving statistical data issues

• Collaborate within Biostatistical study teams and across various departments

• Evaluate the scope of statistical programming work and budgets, identifying out-of-scope tasks

• Create and maintain SDTM and ADaM define.XML/PDF files and reviewer’s guides

• Validate SDTMs, ADaMs, and define.XML files using Pinnacle 21

• Utilize global SAS macros to enhance programming efficiency

• Engage in initiatives related to standard macros, templates, programming standards, and processes

• Stay updated with industry, CDISC, ICH, and regulatory standards

• Review and provide feedback on eCRFs, edit checks, SAPs, and TLF shells

• May serve as Lead Statistical Programmer on individual studies

⛳️ Requirements

• Bachelor’s degree in Statistics, Computing Sciences, or a related field; a master’s degree is a plus

• Minimum of 1 year of clinical research experience in the biotechnology, pharmaceutical, or CRO sectors, including 1 year in Statistical Programming

• Significant familiarity with clinical trial data, SAP, TLF Shells, and specifications

• Proficient working knowledge of SAS; SAS certification is a plus

• Familiarity with XML programming is advantageous

• Strong understanding of CDISC standards and guidelines; CDISC certification is a plus

• Good grasp of the drug development process, ICH guidelines, relevant Health Canada and FDA regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry Good Programming Practices

• Highly organized and detail-oriented, possessing effective project planning and time management skills

• Capable of thriving in a fast-paced environment with proven ability to manage and prioritize multiple competing demands

• Must be able to work independently as well as collaboratively within a team

• Strong verbal and written communication skills in English; proficiency in French is an asset

• Must have legal authorization to work in Canada

🏝️ Benefits

• Permanent full-time employment

• Flexible working hours

• Remote position

• Continuous learning and development opportunities

• Engaging work environment

• Attractive opportunities for career advancement