Senior Biostatistician Consultant – 24 months contract

This is a fully remote position, open to applicants in United States.

📋 Description

• This role involves 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 drafting protocols or amendments as needed.

• Create and compose statistical analysis plans.

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

• The role will also involve supporting submission activities, which include the design, analysis, and reporting of integrated summaries for safety and efficacy.

• Participation in study team meetings and providing statistical contributions are expected.

• Within the BDM Department, leadership capabilities are essential for organizing and scheduling study deliverables in collaboration with Statistical Programmers and Data Managers.

⛳️ Requirements

• MS or PhD in Statistics or Biostatistics is required.

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

• Practical experience in Phase I/II/III clinical trials and proficiency in SAS programming; proficiency in R programming is preferred.

• Strong oral and written communication skills are essential.

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

🏝️ Benefits

• Competitive salary.

• Flexible work hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.