Director Biostatistics

Boston Biomedical is seeking a Director in Biostatistics. The Director in Biostatistics will serve as statistical lead for clinical program, providing statistical expertise to multiple studies, addressing statistical issues arising in regulatory settings, and overseeing CRO statistical/programming activities.

Reporting Relationship:

Head of Biostatistics

Key Responsibilities

  • Serve as biostatistics lead for clinical program, providing statistical expertise in clinical development plan, study design, study operation, decision rule and analysis plan etc.
  • Serve as biostatistics lead in interactions with regulatory agencies, planning, preparing and addressing statistical issues in regulatory documents.
  • Author and/or oversee production of statistical sections of protocols, statistical analysis plans, regulatory documents, and statistical sections of publications etc.
  • Plan, manage and oversee CRO statistical/programming activities

Professional Experience / Qualifications

  • Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trials
  • Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards
  • Strong statistical leadership in a multi-functional project environment
  • Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report
  • Skilled in SAS programming. Knowledge of R programming is a plus.
  • PhD in statistics, biostatistics or related area.
  • Minimum 7-year experience on clinical trial design and analysis is required, including at least 3-year Oncology trial experience.
  • Experience in Hematology clinical trials are a plus.
  • Experience in the interactions with FDA, EMEA/CPMP and other regulatory agencies is required; hands-on filing experience such as ISS/ISE is a plus.

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com