Associate Director, Biostatistician Consultant – 24 months contract
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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• 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
Apply tot his job
Apply To this Job