GI Statistics - Sr Manager
Posted on: May 16, 2022
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Job Description Are you looking for a patient-focused,
innovation-driven company that will inspire you and empower you to
shine? Join us as a Senior Manager, Statistics, GI in our
Cambridge, MA office.
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.
Provide leadership at a compound level on clinical, regulatory, and
commercial development strategies
Promote efficient innovative methodologies and optimal development
Contribute to strategies for statistics related technologies,
processes, and standards
Independently represent the statistics function on global
therapeutic areas in support of clinical studies and compound
and/or TA-level programs.
Provide strategic statistical input to feasibility assessments,
development and submission plans, and defense of regulatory
submissions across therapeutic areas, including timelines.
Provide statistical leadership in the development and review of the
study synopsis, protocol, statistical analysis plan, clinical study
report, and other regulatory submission documents, ensuring
accurate and statistically valid deliverables within and across TAs
Oversee standards of definition and implementation of therapeutic
area level database (including derived database), analysis and
reporting standards. Collaborate with Data Management, Programming,
Safety Statistics, Clinical and PV to provide suggestions for
achieving high quality databases and specifications.
Oversee compound and/or TA-level analysis and reporting
Identify and interact with external statistical experts for issues
related to design, methodology and results as the primary contact
Leverage scientific expertise for strategic statistical leadership
by providing recommendations and statistical consultations to
Monitor and contribute to industry advances in statistical methods
to optimize study designs and statistical analyses techniques, and
lead implementation of innovative approaches within and/or across
TAs as appropriate.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
PhD in statistics or biostatistics with a minimum of 6 years of
relevant experience Expert knowledge of statistical design/analysis
methodology including latest developments and reporting
Strong collaborative skills and ability to work with a
Advanced knowledge of clinical study designs, analysis methodology
and data interpretation.
Advanced knowledge of pharmaceutical industry, overall drug
development process with expertise in the cross-functional
interfaces with the Statistics function.
Advanced knowledge of FDA and ICH regulations and industry
standards applicable to the design, analysis of clinical trials and
Excellent oral and written communications skills.
Expertise in statistical programming, modeling and simulations
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
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
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.
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.
Locations Boston, MA Worker Type Employee Worker Sub-Type Regular
Time Type Full time
Keywords: Takeda, Bethlehem , GI Statistics - Sr Manager, Executive , Frenchtown, Pennsylvania
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