Associate Director, Statistics
Company: Takeda Pharmaceutical
Posted on: August 7, 2022
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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.
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.
At Takeda, we are transforming the pharmaceutical industry through
our R&D-driven market leadership and being a values-led
company. To do this, we empower our people to realize their
potential through life-changing work. Certified as a Global Top
Employer, we offer stimulating careers, encourage innovation, and
strive for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold
- Drives all statistical aspects of biomarker development for
Takeda R&D assets for Oncology Cell Therapy and TA covering
design and analysis from pre-clinical to early clinical
- Drives data driven decision making in multidisciplinary team
environment (comprising of preclinical, biomarker, translational
and clinical scientists, and computational biologists and
quantitative pharmacologists) by providing high level of
statistical rigor to the analyses and interpretation of complex
data generated by translational teams
- 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 Oncology Cell Therapy and TA programs
functional strategy for resourcing, processes and standards to
maximize efficiency and global data integrability.
- Participates in functional and cross functional initiatives
including process and quality improvements.
- Serve as global statistical lead for biomarker development in
Oncology Cell Therapy and TA. Provide statistical leadership and
support for internal decision making, regulatory meetings,
submissions and follow up.
- Review key program documents and presentations (portfolio entry
document, PRC narratives, biomarker strategy plan), attend
Translational Research meetings to develop a comprehensive overview
of the existing data in pre-clinical and translational studies,
form a deep understanding of the development rationale and strategy
and the key questions that need to be answered from biomarker data,
and help the teams identify any statistical shortfalls and propose
solutions to overcome them
- Attend scientific conferences (AACR, ASCO, SITC) and stay
abreast with the latest developments in IO and cell therapy space
with an eye towards acquiring biomarker data that can help augment
- Play a leadership role in development of Exploratory Analysis
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 the biomarker
- 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 integrability; 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- PhD in statistics/biostatistics or in bioinformatics with an
emphasis on statistics with at least 6 years of relevant industry
experience or MS in statistics with at least 10 years of relevant
- Team work is key for this role. Candidate will be expected to
routinely interface with other quantitative 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 inlcuding 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
- Expert knowledge of statistical approaches for assays, and
biomarker development and validation.
- 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.
- Knowledge of IO Biology and experience working with raw data
from emerging biomarker technology platforms in the space (CyToF,
TCRSeq, Multiplexed IHC) is a plus
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs
Absent an approved religious or medical reason, all US office-based
and lab-based Takeda employees who work fully on-site or in a
hybrid model (as determined by Takeda) must be fully vaccinated to
work at a Takeda site or to engage with Takeda colleagues or anyone
else on behalf of Takeda. US field-based employees must be fully
vaccinated as a condition of employment, absent an approved
religious or medical reason. US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. If you are
contacted by a Takeda recruiter about your job application, we
encourage you to seek more information on the applicable guidelines
for the Business Unit/Function to which you have applied.
Empowering Our People to Shine
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In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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, Boston , Associate Director, Statistics, Executive , Maynard, Massachusetts
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