Associate Director Biostatistician

Job Summary

Associate Director Biostatistician, a full-time remote position responsible for leading biostatistical contributions to clinical studies, including protocol design, statistical analysis plans, and regulatory submissions over a 24-month contract.

Key Responsibilities

• Independently contribute to the design of early/late-stage protocols and draft statistical analysis plans
• Perform statistical analyses for interim and final reports and support submission activities
• Collaborate with study team members and lead the organization of study deliverables within the Biostatistics Department

Required Qualifications and Education

• MS or PhD in Statistics or Biostatistics
• PhD + 6 years or MS + 11 years of clinical trial experience in biotechnology or pharmaceutical companies
• Hands-on experience with Phase I/II/III clinical trials and proficiency in SAS programming; R programming is desirable
• Previous experience with regulatory submissions is a plus