Senior Biostatistician Consultant – 24 months contract

📋 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.

• Assist in drafting protocols or amendments.

• Create and compose statistical analysis plans.

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

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

• Participation and statistical input during study team meetings are anticipated.

• Within the BDM Department, leadership capabilities are essential to aid in the organization and scheduling of study deliverables in conjunction 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 with Phase I/II/III clinical trials and proficiency in SAS programming; excellence in R programming is preferred.

• Exceptional oral and written communication skills.

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

🏝️ Benefits

• Health insurance.

• Professional development opportunities.