Associate Director, Statistics
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 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 and . 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
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
mission.POSITION OBJECTIVES:
- 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
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, 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.POSITION
ACCOUNTABILITIES:
- 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
internal data
- 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
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 at least 10 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 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
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.
- 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
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 ProgramsAbsent 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
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.#LI-SGMEEO 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 , Associate Director, Statistics, Executive , Cherry Hill, New Jersey
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