• MS or PhD in Statistics or Biostatistics
• >5 years clinical trial experience in either a biotechnology or pharmaceutical company
• Hands-on Phase IIb/III clinical trial experience and proficient in SAS programming
• Excellent oral and written communication skills, and proficient in presenting power point presentations
• Although not required, previous support of regulatory submissions in the US, Europe, or Japan
• Although not required, previous clinical trial experience in the therapeutic areas of dermatology and/or oncology
• No Direct reports initially
This position is responsible for working with study team members to design late stage protocols, develop and write statistical analysis plans, and perform statistical analyses for interim and final reports to be submitted to regulatory agencies. The position will also support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy. Attendance and statistical contributions at study team and project team meetings are expected. Within the BDM Department, leadership skills are needed to organize and schedule deliverables among the statisticians, SAS programmers and data managers. All BDM members are expected to support department infrastructure projects on an annual basis, including SOP improvement, development of white papers for innovative statistical methodology, new software user testing and support, etc… Mentoring opportunities are also available.
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