Biostatistics Jobs
- Participate in protocol development and planning process, including study designs, selection of endpoints, sample size determination and preparation of statistical section of the protocol
- Prepare and present statistical analysis plans to regulatory agencies
- Apply complex statistical methods, analyze clinical study data and provide programming and validation support
- Prepare statistical section of clinical trial reports or other statistical documents in support of a NDA
Skills:
- Ph.D. in statistics/biostatistics
- 2+ years of clinical research experience
- Experience with a variety of statistical methods and ability to work on complex statistical problems
- Solid SAS experience and familiarity with other statistical software packages
- Familiarity with relevant ICH and FDA guidelines
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*Job responsibilities and skills required will vary across hiring organizations