VP, Biostatistics

Vice President, Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including, protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at sponsor.
Responsibilities:

• Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis and reporting of clinical trial data
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• Oversee CRO statistical activities and manage contractor statisticians to ensure timely delivery of high-quality statistical outputs
• As the biostatistics representative, proactively collaborate with internal and external team members in the assigned projects, accountable for all statistics deliverables
• Contribute to the biostatistics vendor evaluation and selection
• Provide a thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• Contribute to the development of Biostatistics SOPs and standards
• Support study/program-level audit and inspection readiness activities as needed
• Develop and maintain advanced competencies in statistical methodology and advanced trials designs, particularly in oncology drug development

Vice President, Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including, protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at sponsor.
Responsibilities:

• Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis and reporting of clinical trial data
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• Oversee CRO statistical activities and manage contractor statisticians to ensure timely delivery of high-quality statistical outputs
• As the biostatistics representative, proactively collaborate with internal and external team members in the assigned projects, accountable for all statistics deliverables
• Contribute to the biostatistics vendor evaluation and selection
• Provide a thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
• Contribute to the development of Biostatistics SOPs and standards
• Support study/program-level audit and inspection readiness activities as needed
• Develop and maintain advanced competencies in statistical methodology and advanced trials designs, particularly in oncology drug development

• Minimum of MS required (Ph.D. preferred) in Statistics, Biostatistics, or other related fields
• MS with 15+ years (Ph.D. with 8+ years) of overall experience, including at least 12+ years (at least 6+ years for Ph.D.) of experience in drug development in a CRO or pharma/biotech company
• Oncology experience is required: familiar with oncology drug development, both early and late stage, including efficacy endpoints, common statistical issues and study designs in oncology
• Regulatory NDA/BLA submission experience is strongly preferred
• Must have hands on experiences with SAS programming in clinical studies
• Experience with managing CROs and contractors
• Excellent project management skills and proven ability to manage competing priorities