Our client a clinical stage biotechnology company is seeking a Biostatistician to join their team for a 1-year contract. As the Biostatistician you will participate in developing plans for clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process. The Biostatistician will provide technical support for ongoing clinical trials, publications, and other business needs.
Principal Responsibilities
· Provide statistical expertise into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives
· Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, data management, statistical programming, medical writing etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, and serve as internal statistical expert in the overall program
Qualifications
· 10+ years of experience with MS or 7+ year of experience with Ph.D. in clinical drug development. Prior experience working with oncology studies (solid tumor or hematologic malignancies) is highly preferred. Past NDA/BLA submission experience is desirable.
· Proficiency in statistical programming languages/software such as SAS, R, etc.
· Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process.
· Demonstrated written and oral communication skills and ability to work within a team and work independently are required.
· Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.
· Desire to work in a fast-paced, innovative environment
Education
· MS/Ph.D. in Statistic, Biostatistics, Mathematics or related field
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