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Statistical Programmer

1 month ago

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

We are seeking a skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc. as part of our ongoing efforts to deliver high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries.

The successful candidate will be responsible for developing and reviewing SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF), and other related documents based on the Statistical Analysis Plan (SAP), company Standard Operating Procedures (SOPs), and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements.

The key responsibilities of this role include:

  • Developing and reviewing SDTM and ADaM dataset specifications, annotated CRF, and other related documents based on the SAP, company SOPs, and WIs, industry data standards, regulatory requirements, and trial Sponsor-specific requirements.
  • Programming and validating SDTM and ADaM datasets following approved dataset specifications; performing CDISC conformance checks on generated SDTM and ADaM datasets and addressing conformance findings.
  • Developing SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells.
  • Providing statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations, as well as other data analysis and reporting needs such as regulatory required safety reports, ad-hoc requests, and exploratory data analyses.

The ideal candidate will have 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 Programmer. Exposure/experience in clinical trial statistical programming and/or data analysis is desirable.