Associate Director, Statistics, Rare Genetic Hematology

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, Statistics, Rare Genetic Hematology, Executive , Cambridge, Massachusetts