Senior Manager, Biostatistician Consultant

📋 Description

• This role entails collaborating with study team members and the project statistician to aid in the design of early and late-stage protocols across various therapeutic areas, assist in drafting protocols or amendments, create and compose statistical analysis plans, and execute statistical analyses for both interim and final reports intended for regulatory agency submissions.

• The position will also assist with submission activities, which include the design, analysis, and reporting of integrated summaries for safety and efficacy.

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

• Within the BDM Department, strong leadership abilities are essential to aid 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 either a biotechnology or pharmaceutical setting

• Practical experience in Phase I/II/III clinical trials and proficiency in SAS programming. Expertise in R programming is highly desirable.

• Outstanding oral and written communication abilities.

• While not mandatory, prior experience with regulatory submissions in the US, Europe, Japan, and other regions is preferred.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuing education.

• Flexible working hours and remote work options.