About this role

This position is responsible for working with study team members and the project statistician to contribute to design of early/late-stage protocols across multiple therapeutic areas, help draft protocols or amendments, 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 meetings are expected.
Within the BDM Department, leadership skills are needed to 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 +4 years (or MS +9 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.
Although not required, previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World, is desirable.

Senior Manager, Biostatistician Consultant

Key skills