Statistical Programmer

2 weeks ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We are seeking a highly skilled and customer-focused individual to join our team as a Statistical Programmer for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada.

Key Responsibilities:

  • Statistical Programming: Develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents based on Statistical Analysis Plan (SAP), company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements.
  • Clinical Data Acquisition and Cleaning Support: Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review.
  • Document data and programming information: Document data and programming information in accordance with company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.
  • Key Performance Indicators: Achieve a high rating for each of the defined company and trial Sponsor-specific statistical programming key performance indicators.
  • Professional Development: Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable.

Requirements:

  • A Master's or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences, with SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred; with exposure/experience in clinical trial statistical programming and/or data analysis is desirable.

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