Statistical Programmer

September 17

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Endpoint Clinical

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IVR/IWR for clinical trials • IRT • Randomization • Clinical Supply Chain Management • ePRO

501 - 1000

💰 $1.7M Debt Financing on 2010-03

Description

• Consult with clients on statistical approaches as required. • Write, modify, and maintain statistical programs and macros that produce randomization files, data sets, tables, and listings for assigned projects. • Review study protocols and randomization requirements to create and verify randomization and kit lists. • Ensure the integrity of the randomization process within the IRT system(s). • Document and manage new and existing randomization lists. • Develop simulation programs to evaluate dynamic randomization models. • Review Statistical Analysis Plans and provide feedback to the author(s). • Perform other duties as required and assigned.

Requirements

• 4+ years of statistical programming experience, preferably in processing clinical trial data. • Experience in statistical programming languages and software such as SAS, R, and Python required. SAS Certification(s) are highly preferred. • Prior experience in IRT platforms, eClinical technologies, life sciences, or regulated industries is highly preferred. • Knowledge of regulatory guidelines such as 21 CFR Part 11 and GxP.