Senior Clinical Biostatistician, PhD
Reporting to the Director of Clinical Biostatistics, the Senior Statistician's primary responsibilities will include the following:
- Participate in the design and review of clinical protocols and case report forms including preparation of statistical sections, sample size calculations, randomization, and study design recommendations
- Prepare detailed statistical analysis plans (including shell tables and listings)
- Provide detailed specifications to SAS programmers for generating SAS analysis datasets for efficacy and safety analyses
- Perform efficacy analyses to determine the difference in efficacy between test drug and controlled drug in clinical trials
- Perform safety parameter analyses to assess the safety profile of test drug compared to that of controlled drug in clinical trials
- Review study summaries and data displays for consistency with the statistical analysis plan and recommended approval or revision
- Provide advice and guidance to the data management and statistical programming team
- Coordinate data and table review activities among the project team
- Communicate with clients regarding study protocol and statistical analysis issues
The successful candidate will have a combination of the following skills/experience:
- Ph.D. degree in Statistics, Biostatistics, Social Sciences, or other relevant academic field
- Minimum of 7+ years professional experience in a Life Sciences setting (ideally in Pharmaceuticals and/or CRO)
- Thorough knowledge of regulatory submissions process
- Strong writing, oral & presentation skills
- Knowledge of clinical trials conduct and the data and reporting requirements for clinical trials
- Knowledge of the practical application of principles, techniques, procedures and equipment used in the design and production of files, tables, listings, figures/graphs, edit checks, ad hoc programs, statistical analysis plans and efficacy / safety analysis
Octagon is an Equal Opportunity Employer with an outstanding corporate culture. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.
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