Associate Director, GI Statistics
Company: Takeda Pharmaceutical
Posted on: January 23, 2023
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About the role: 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.
Here, teamwork is everything. Drug discovery, design and
development is increasingly more complex and every individual on
the team matters to the success of our inspiring, bold mission. You
are guaranteed to be a vital contributor to everyone's success,
most importantly your own. As an Associate Director, Statistics,
you will be empowered, and will have the opportunity to serve as
scientific leader who will provide statistical leadership in the
design, analysis, and interpretation of clinical and translational
studies at both the compound and therapeutic area (TA) levels,
promoting innovative designs and methodologies.
How you will contribute:
- Drives all statistical aspects of development for Takeda
R&D assets for GI TA covering design and analysis from early
clinical to registrational studies.
- Drives data driven decision making in multidisclipinary team
environment by providing high level of statistical rigor to the
analyses and interpretation of complex data generated.
- 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 GI TA programs 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 GI TA. Provide statistical
leadership and support for internal decision making, regulatory
meetings, submissions and follow up.
- Review key program documents and presentations, attend meetings
to develop a comprehensive overview of the existing data, form a
deep understanding of the development rationale and strategy and
the key questions that need to be answered from data, and help the
teams identify any statistical shortfalls and propose solutions to
- Attend scientific conferences and stay abreast with the latest
developments in GI
- Play a leadership role in development of Clinical Development
Plans and completion of major statistics deliverables and
milestones in collaboration with other functions
- Stay up-to-date on emerging technologies and associated data
analytic techniques, external databases and novel methodologies
that can help Takeda derive the maximum value out of data
- 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 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
- Active participation in external professional initiatives and
organizations to identify industry best practice and its
applicability in Takeda. Minimum Requirements/Qualifications:
- PhD in statistics/biostatistics with an emphasis on statistics
with at least 5 years of relevant industry experience or MS in
statistics with at least 8 years of relevant industry
- Team work is key for this role. Candidate will be expected to
routinely interface with other functions in industry and must have
strong inter-personal and people management skills, and ability to
influence others, without direct hierarchical authority, to affect
change across organizational boundaries.
- Expert knowledge across broad areas of statistical
methodologies including subgroup analysis, longitudinal data
analysis, multivariate methods, predictive modeling, machine
learning, Bayesian modeling. Strong background in statistical
modeling in R or SAS with the ability to independently code
- Advanced knowledge of pharmaceutical industry, overall drug
development process with expertise in the cross-functional
interfaces with the Statistics function.
- Excellent oral and written communications skills.
- Strong project management skills. What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement Base Salary Range: $ 143,000 to $205,000
. Employees may also be eligible for Short Term and Long-Term
Incentive benefits. Employees are eligible to participate in
Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days & Vacation, Tuition
Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Keywords: Takeda Pharmaceutical, Newark , Associate Director, GI Statistics, Executive , Newark, New Jersey
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