Statistical Programmer I

Location: Markham, Ontario (on-site) or remotely from a home-based office anywhere in Canada, in accordance with our Work from Home policy.

Accountabilities

• Under supervision, develop and review SDTM and ADaM dataset specifications, annotated CRFs, and related documents based on SAP, company SOPs, WIs, industry standards, regulatory requirements and sponsor‑specific requirements.
• Program and validate SDTM and ADaM datasets following approved specifications; perform CDISC conformance checks and address findings.
• Develop SAS programs to generate and validate statistical output reports of trial data based on SAP and TLGs mock‑up shells.
• Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations, regulatory‑required safety reports such as Development Safety Update Report, 120 Day Safety Update, ad‑hoc requests, and exploratory d...