Senior Statistician
$87,500–$173,500 year
RemoteUnited States
Job Summary
Independently manage statistical project support and provide expert consultancy across the stats function. Review study designs, analysis plans, and reports while assisting sponsors in designing clinical trials, including statistical sections of protocols and randomization methodologies. Develop, evaluate, and run SAS programs for derived datasets, CDISC, SDTM, and ADaM datasets, ensuring validation and documentation maintenance. Produce final reports, tables, listings, and figures, and contribute to manuscripts for publication. Lead system and process improvements to enhance data processing efficiency and support bidding processes. Perform all activities in compliance with ICH standards, FDA regulations, and sponsor quality systems.
Required Qualifications
- Master's level in mathematics, statistics, or another subject required with a strong statistical component
- Minimum 3 years of statistical experience leading clinical trial projects and data analysis
- Expert-level project statistician experienced in providing statistical leadership to projects
- Design and analysis consultancy skills and knowledge across a broad range of applications
- Computer literate and numerate with a proven ability to adapt to various computer systems
- Knowledge in design consultancy and analysis methodology
- Knowledge of statistical software packages (e.g., SAS and nQuery)
- Knowledge of regulatory guidance documents, e.g. International Council for Harmonization (ICH), Food and Drug Administration (FDA), and Committee for Medicinal Products (CPMP) points to consider
- Knowledge of FDA Quality System Regulation (including 21CFR Part 11)
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