Senior Manager, Biostatistician Consultant – 24 months contract

📋 Description

• Accountable for collaborating with study team members and the project statistician to assist in the design of early and late-stage protocols across various therapeutic areas.

• Aid in the drafting of protocols or amendments.

• Create and compose statistical analysis plans.

• Conduct statistical analyses for interim and final reports intended for submission to regulatory bodies.

• Provide support for submission activities, which includes the design, analysis, and reporting of integrated summaries for safety and efficacy.

• Participation and statistical contributions at study team meetings are anticipated.

• Assist in the organization and scheduling of study deliverables in partnership with Statistical Programmers and Data Managers.

⛳️ Requirements

• MS or PhD in Statistics or Biostatistics.

• PhD with 4 years (or MS with 9 years) of clinical trial experience in a biotechnology or pharmaceutical setting.

• Practical experience in Phase I/II/III clinical trials and proficiency in SAS programming. Proficiency in R programming is a plus.

• Outstanding oral and written communication skills.

• While not mandatory, prior experience with regulatory submissions in the US, Europe, Japan, and the Rest of the World is preferred.

🏝️ Benefits

• Opportunities for professional development.