Senior Statistical Assistant Jobs in Quebec

Experience: 7 to 20 years

· Ensure that regulatory requirements are met through validation/compliance activities.

· Other responsibilities as assigned.

· Knowledge of statistics, programming and/or clinical drug development process

· Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language

· Exhibits routine and occasionally complex problem-solving skills

Strong written and oral communication skills, and project management skills

Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.

At least some relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

Good understanding of ICH and Regulatory Guidelines including submission requirements and data conformance (e.g., Pinnacle21)

Statistical Programming and SAS, R, or Python hands-on experience

Working knowledge of clinical data and relevant data standards (e.g., CDISC)

Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines

You love working on a team and providing collaborative input to others, working well with data and project management

You are a strong SAS programmer, experienced in supporting the analysis of clinical trial data

You have excellent written and verbal communication skills

Principal Statistical Programmer: Minimum 8 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial Statistical Programmer

Senior Statistical Programmer: 5-7 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial Statistical Programmer