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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