Director, Statistics, Rare Genetic Hematology
Company: Takeda Pharmaceutical Company Ltd
Posted on: June 12, 2021
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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
- Serves as global statistical expert for major development
programs, with potential for leading and managing a team of
- 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
- 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,
- 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
- Promote innovative clinical trial designs and efficient
- Play a leadership role in development and completion of major
statistics deliverables and milestones in collaboration with other
- Drive/participate in development and implementation of global
systems, processes and standards to maximize quality and
- 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.
- 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
- 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
- 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
- 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
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- 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.
Keywords: Takeda Pharmaceutical Company Ltd, Boston , Director, Statistics, Rare Genetic Hematology, Other , Boston, Massachusetts
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