Executive Director, Biostatistics

Overview of Role : The Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects, providing strategic and technical leadership, as well as statistical support, in the development and execution of statistical strategies, study designs, statistical analyses, and regulatory submissions. They will collaborate with clinical science, regulatory and other functions on clinical development plans, the authorship of key clinical, regulatory, statistical documents, and ensuring the high-quality delivery and accurate interpretation of clinical data.The Executive Director will develop and implement biostatistics department policies, standards, procedures, and work instructions in coordination with the department leader and other functions. Additionally, they will represent biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies. This role includes direct supervisory responsibilities for internal staff or external consultants.Role and Responsibilities : Serve as the Biostatistics Lead for multiple oncology projectsProvide strategic and technical leadership, along with statistical support, to clinical development in the design and conduct of late-stage oncology trialsProvide strategic input and guidance to ensure the high quality of Regulatory Authority documents, including clinical protocols, statistical analysis plans, study reports, briefing books, submissions, and safety reportsCollaborate with cross-functional teams to ensure accurate interpretation of study results and high-quality study reports and publicationsWrite and review sections of meeting packages, and assist in the development and review of other documents required for regulatory submissions and processesLead the assessment and implementation of novel statistical methodologies to drive solutionsRepresent the biostatistics function or biometrics department in cross-functional teamsCollaborate with the department leader to develop and implement policies, standards and proceduresDevelop strong, collaborative relationships with key business stakeholders, including project leaders in Regulatory, Clinical Development, Clinical Operations, Research and other functionsAssess and manage CROs and other vendors, including scope-of-work, timelines, deliverables, and budgetsStay up to date with FDA and EMA regulations, guidance, emerging trial designs for marketing authorization, and communicate relevant updates to key stakeholdersParticipate in meetings with FDA and other health authorities to ensure alignment on project developmentProvide mentorship and coaching to direct reports to help them reach their full potentialAll other duties as assignedExperience, Education and Specialized Knowledge and Skills : Ph.D. in Statistics, Biostatistics or equivalent area with 15 years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (18 years) can be considered.A minimum of 3 years of experience in team leadership and managing direct reports is required10 years of experience in oncology clinical trials, including trial design and execution, with a strong background in late-stage clinical trialsExtensive knowledge of clinical trial development and statistical methodologies related to trial design and execution is required, with experience in late-stage oncology trials and regulatory submissions essentialExperience in providing statistical support for Medical Affairs and Market Access activities is highly preferredExperience interacting with health authoritiesComprehensive knowledge of ICH, FDA, and GCP regulations and guidelines, with strong, well-rounded technical skillsExcellent organizational skillsCritical thinking, problem solving, ability to work independentlyMust be able to effectively multi-task and manage time-sensitive and highly confidential documentsCommunicate effectively and articulate complex ideas in an easily understandable wayWork in a fast-paced, demanding and collaborative environment#J-18808-Ljbffr