Associate Director

Company: Takeda
Location: Cambridge
Posted on: February 20, 2021

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

Keywords: Takeda, Cambridge , Associate Director, Executive , Cambridge, Massachusetts