The Director of Biostatistics provides direction on product development plans, protocols and analysis, reviews study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. This position is responsible for implementing consistent statistical conduct for testing implementation throughout the organization. The position also provides guidance to the department towards achieving departmental and corporate visions and goals. The Director maintains liaison with research and development, clinical laboratory, and quality assurance personnel in order to identify and meet their needs for statistical support.
Draft statistical analysis plans and use advanced statistical techniques to analyze clinical laboratory data as well as product verification and validation study results.
Provide strategic input to development programs including filing strategies worldwide, study design, analytic methods, and endpoints that meet both regulatory and scientific requirements.
Collaborate with functional areas within the company (Clinical Laboratory, Regulatory and Research and Development).
Make presentations and represent biostatistics to senior management, external collaborators and thought leaders, FDA meetings, FDA advisory boards and medical and statistical meetings.
Provide statistical direction and technical oversight for complex projects requiring statistical input.
Support the presentation and publication of study results and contribute to advances in statistical topics.
Ensure the scientific integrity of the statistical methodology applied to clinical trials, verification and validation protocols, and other key product tests.
Strategically select resources to provide for analytic needs, and clarify long-term resourcing plans.
Clarify project deliverables and timelines for statistical analysis and reporting, and ensure that they are met.
Provide leadership and direction for organization strategic initiatives.
A Ph.D. degree in Statistics, Biostatistics or equivalent areas with 5+ years or MS degree with 10+ years of relevant industry or FDA experience in the statistical analysis of biomedical data.
4+ years of scientific programming experience with SAS.
Diagnostic experience in oncology and submission experience with PMAs and companion diagnostics are preferred.