Director, Statistics, Rare Genetic Hematology

Company: Takeda Pharmaceutical Company Ltd
Location: Boston
Posted on: June 12, 2021

Job Description:

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Statistics Rare Genetic Hematology in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director, Statistics Rare Genetic Hematology working on the team, you will be responsible for the adoption and utilization of technologies, models and methods for science-driven data analytics across R&D, and a typical day will include:

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

This job posting excludes CO applicants.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Keywords: Takeda Pharmaceutical Company Ltd, Boston , Director, Statistics, Rare Genetic Hematology, Other , Boston, Massachusetts