Associate Director, Statistics, Rare Genetic Hematology

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Boston, Massachusetts

Expiry Date :
Sat, 05 Dec 2020 23:59:59 GMT

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By clicking the Apply button, I understand that my employment applic process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use. Job_Description Objective * Serves as global statistical expert for major development programs, with potential for leading and managing a team of statisticians * Oversees all statistics activities for one major clinical program or multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. * Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up. * Establishes and drives therapeutic area(s) program functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability. * Participates in functional and cross functional initiatives including process and quality improvements, Accountabilities * Serve as global statistical lead for assigned therapeutic areas or phase of development or CMC/non-clinical activities. * Lead and manage team of statisticians supporting cross region studies and programs for identified therapeutic area(s) or phase of development or CMC/non-clinical activities; manages assignments and priorities of team members. * Develop and mentor staff by utilizing appropriate internal and external resources to achieve short term and long term strategic functional goals. * Promote innovative clinical trial designs and efficient analysis methodologies * Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions. * Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency. * Leverage standardized analysis methods and reporting standards to maximize global data integratability; identifies best practice for utilization across programs. * Provide statistical leadership and support for regulatory meetings, submissions and follow up. * Provide or identify internal and external statistical expertise and capacity to support development activities. * Collaborate/lead in the development of compound/program-level sourcing/ vendor strategies and provide oversight of statistical services, ensuring overall quality. * Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. * Provide input for planning and management of external budgets related to statistical deliverables. * Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in Takeda. Requirements * PhD in statistics or biostatistics with at least 8 years of relevant pharmaceutical industry experience * Experience with at least two NDA/CTDs or other regulatory submissions. * Experience representing Statistics function in interactions with regulatory agencies. * Advanced knowledge of clinical study designs, analysis methodology and data interpretation. * Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function. * Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. * Strong statistical programming skills * Excellent oral and written communications skills. * Specialized statistical expertise in multiple therapeutic areas or development phases. * Strong inter-personal and people management skills. * Strong project management skills. * Strong collaborative skills and ability to work with a cross-functional team. * Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries. * Ability to inspire and motivate staff Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Show moreShow less