Director/Sr Director Biostatistics
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About The Position
In this new role, reporting to the Vice President of Biometrics, you will be working with cross-functional clinical teams responsible for statistical activities across clinical programs. This includes overseeing statistical deliverables that are outsourced to clinical Contract Research Organizations (CROs). As a biostatistics expert for clinical programs, you will provide strategic input to optimize trial designs in late-phase registrational studies. Your proactive collaboration with internal and external CRO team members will be essential in coordinating the planning and execution of statistical deliverables. You will conduct statistical modeling to enable robust and efficient statistical designs, addressing any identified or potential statistical issues that may arise during studies. Your contributions will extend to clinical protocol development, where you will author or review the Statistics section and apply statistical principles to review other sections. Additionally, you will be responsible for authoring or reviewing the development of statistical analysis plans for clinical trials, overseeing the creation of tables, figures, listings, and associated deliverables. Your role will also involve reviewing electronic case report form (eCRF) designs to ensure that data collection meets the requirements for statistical analyses. You will provide statistical input for clinical documents and perform quality control and quality assurance of statistical deliverables, including the validation of key analysis results. Ad hoc statistical analyses may be required as needed, and you will contribute to clinical study reports by authoring statistical methods and interpreting study results. You will be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions, providing thorough reviews for required components of these submissions, including appropriate datasets, define files, reviewer's guides, and other relevant documents. Addressing statistical questions and comments from the FDA and other regulatory agencies, as well as from Institutional Review Boards (IRBs) or Ethics Committees (ECs), will also be part of your responsibilities. Furthermore, you will support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations. Leading standardization and process improvement efforts for the Biostatistics function, you will also contribute to cross-functional process improvement efforts, including the definition of biostatistics templates and standards. Representing the organization in meetings with external parties, including regulatory agencies and corporate partners, will be expected, along with supporting inspection readiness activities as needed. You will be required to develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development, while also taking on additional duties and responsibilities as required.
