Senior Biostatistician
$87,500–$173,500 year
On-siteResearch Triangle Park, North Carolina, United States
Job Summary
Independently manage statistical project support and provide expert consultancy across the statistics function. Lead statistics support for one or more projects, ensuring needs are met through timely review of study designs, analysis plans, and reports. Liaise with internal departments, sponsors, and third parties regarding statistical issues, while assisting sponsors in designing clinical trials, including statistical sections of protocols and analysis plans. Develop, test, and run SAS programs for derived datasets, CDISC SDTM, and ADaM datasets, ensuring program validation and documentation maintenance. Prepare final reports, including tables, listings, figures, and report writing, and contribute to manuscripts for publication. Support the bidding process, lead system improvement initiatives, and assist with Quality Assurance and audit requirements in compliance with ICH, FDA, and Worldwide standards.
Required Qualifications
- Hands-on expert-level project statistician experienced in providing statistical leadership to projects
- Design and analysis consultancy skills and knowledge across a broad range of applications
- Customer focus
- Delivering on commitments
- Building strong relationships
- Communicating and influencing
- Embracing innovation and change
- Education to degree level in mathematics, statistics, or another subject with a strong statistical component
- Computer literate and numerate
- Proven ability to adapt to various computer systems
- Knowledge of design consultancy and analysis methodology
- Knowledge of statistical software packages (e.g., SAS and nQuery)
- Knowledge of regulatory guidance documents, including International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and Committee for Proprietary Medicinal Products (CPMP) points to consider
- Maintenance of documentation, including descriptions of programs and validation
- Validation and testing documentation
- Compliance with Worldwide Clinical Trials and agreed sponsor quality system standards
- Compliance with relevant International Council for Harmonisation (ICH) standards
- Compliance with Food and Drug Administration (FDA) Quality System Regulations, including 21 CFR Part 11
Desired Qualifications
- Experience with SAS macros
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