Job Description: Represent the Biostatistics function for complex studies or at project level Independently contribute to the design of early/late-stage protocols across multiple therapeutic areas Draft protocols or amendments, develop and write statistical analysis plans, perform statistical analyses for interim and final reports to be submitted to regulatory agencies Support submission activities, including design, analysis, and reporting of integrated summaries for safety and efficacy Attend study team meetings or project level meetings if needed Contribute to the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers Requirements: MS or PhD in Statistics or Biostatistics PhD + 6 years (or MS + 11 years) clinical trial experience in either a biotechnology or pharmaceutical company Hands-on Phase I/II/III clinical trial experience and proficient in SAS programming. Excellence in R programming desirable. Excellent oral and written communication skills. Previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World is desirable. Benefits: Professional development Opportunities to work independently Supportive culture
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