Senior Manager, Statistics
Company: Takeda Pharmaceutical
Location: Haddon Heights
Posted on: June 25, 2022
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Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a Senior
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 Therapeutic Area Unit
(OCTAU) covering design and analysis from pre-clinical to early
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 OCTAU 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
OCTAU. Provide statistical leadership and support for internal
decision making, regulatory meetings, submissions and follow
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 internal
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 other equivalent quantitative
sciences with an emphasis on statistics with -3 years of relevant
industry experience or MS in statistics with -6 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, communication, and people
management skills, and ability to influence others, without direct
hierarchical authority, to affect change across organizational
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 relevant
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 contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
This job posting excludes Colorado applicants.
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
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, Philadelphia , Senior Manager, Statistics, Executive , Haddon Heights, Pennsylvania
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