About this role

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

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.

Associate Director, Biostatistician Consultant – 24 months contract

Key skills