Boston Biomedical is seeking a Director in Biostatistics. The Director in Biostatistics will serve as
Head of Biostatistics
- Serve as biostatistics lead for clinical program, providing statistical expertise in
clinicaldevelopment plan, study design, study operation, decision rule andanalysis plan etc.
- Serve as biostatistics lead in interactions with regulatory agencies, planning, preparing and addressing statistical issues in regulatory documents.
- Author and/or oversee
productionof 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
teamclearly and help teamunderstand complex statistical design, methodology, decision rule, analysis plan andstatistical report
- Skilled in SAS programming. Knowledge of R programming is a plus.
PhDin 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
- Experience in the interactions with FDA, EMEA/CPMP
andother regulatory agencies is required; hands-on filing experience such as ISS/ISE is a plus.
Job Location: Cambridge, MA
Please send resumes to email@example.com