We're looking for a Director of Biostatistics to influence and drive the statistical and data management strategy within the organization and be responsible for providing statistical input into the design of clinical/translational/preclinical studies, protocols, and statistical analysis plans, while also overseeing key quantitative scientific and data management functions including clinical pharmacology, statistical programming, and data management.
Responsibilities:
Provide scientifically rigorous statistical input into the company's clinical development plans, dose-finding strategies, regulatory strategies, publications, as well as translational and preclinical/discovery projects as needed
Oversee other related internal or external functions, including statistical programming, data management, and clinical pharmacology and develop of strategies and operating procedures for these functions
Serve as the primary statistical author or reviewer of protocols, statistical analysis plans, clinical study reports and other projects as needed
Collaborate closely with clinical science, regulatory and other functions to drive quantitative decision-making during drug development
Requirements:
Ph.D. in Statistics (or related field) plus minimum of 5-10 years experience in biotech/pharma, preferably in oncology
Thorough understanding of statistical principles, clinical trial methodology and data management, including deep familiarity with CDISC standards
Working knowledge of SAS
Experience in PK/PD modelling and simulations
Ability to develop innovative statistical/technical solutions to complex problems
Understanding of the drug development process and guidelines from pre-IND through registration
Knowledge and experience in meeting regulatory guidance, both FDA and international regulatory agencies
