Statistical Programmer - Remote

Overview

The Statistical Programmer will be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Statistical Programmer will also support Data Management (DM) with data cleaning activities, use global SAS macros, participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate the SDTMs, ADaMs, and define.XMLs.

In Short

• Develop, maintain, and validate annotated Case Report Forms (aCRFs).
• Statistical programming of SDTM and ADaM datasets.
• Support Data Management with data cleaning activities.
• Use global SAS macros to enhance programming efficiency.
• Collaborate within Biostatistical study teams.
• Ensure compliance with ICH guidelines and regulatory standards.
• Participate in internal initiatives to improve programming processes.
• Act as a Lead Statistical Programmer when required.
• Coach junior Statistical Programmers.
• Stay updated with industry standards and guidelines.

Requirements

• Bachelor’s degree in Statistics, Computing Sciences or a related field.
• At least 1 year of clinical research experience.
• Excellent working knowledge of SAS; SAS certification is an asset.
• Knowledge of XML programming is a plus.
• Good knowledge of CDISC standards and guidelines.
• Organized and detail-oriented with project planning skills.
• Ability to work independently and as part of a team.
• Strong communication skills in English; French is an asset.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Complete benefits package (medical, dental, vision, etc.).
• Possibility of working from home.
• Ongoing learning and development opportunities.