Senior Manager Biostatistician Consultant Remote in US (24 months contract)

ClinChoice

1d • Remote

About The Position

ClinChoice is searching for an Senior Manager Biostatistician Consultant to join one of our clients. This is a client-facing role where candidates are expected to work independently while establishing a high-trust environment with the client's counterparts. The position is responsible for working with study team members and the project statistician to contribute to the 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.

Requirements

• 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
• Proficient in SAS programming
• Excellent oral and written communication skills

Nice To Haves

• Excellence in R programming desirable
• Previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World, is desirable

Responsibilities

• Contribute to design of early/late-stage protocols across multiple therapeutic areas
• Help 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 and provide statistical contributions
• Contribute to the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers

What This Job Offers

• Job Type: Full-time
• Career Level: Senior