Director, Statistics
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 10, 2022
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Notice and Terms of Use. I further attest
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Director, Statistics.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 mission.POSITION OBJECTIVES:
- Drives all statistical aspects of biomarker development for
Takeda R&D assets, potentially across all Therapeutics Area
Units (Oncology and Cell Therapy, Neuroscience, GI and Rare
Disease), covering design and analysis from pre-clinical to early
clinical studies.
- 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, clinical
development plans, complex study designs, and cross-study analyses,
including input related to identifying key scientific questions,
statistical methodology, interpretation and analyses, and
regulatory submissions.
- Establishes and drives 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.POSITION
ACCOUNTABILITIES:
- Serve as translational statistics support on a
multidisciplinary team that builds translational strategy for
Takeda R&D assets, including identification and validation of
biomarkers to support internal decision making in early clinical
development and analysis of external datasets to support innovative
clinical trial designs.
- 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.
- Play a leadership role in the writing and 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
data
- 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 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
deliverables.
- 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 -8+ years of relevant industry
experience
- 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 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 programs.
- 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.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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.This position is currently classified as
"hybrid" in accordance with Takeda's Hybrid and Remote Work
policy.EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Director, Statistics, Executive , Cherry Hill, New Jersey
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