GI Statistics - Sr Manager
Company: Takeda Pharmaceutical
Location: Salem
Posted on: May 12, 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,
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.POSITION OBJECTIVES:
- Provide leadership at a compound level on clinical, regulatory,
and commercial development strategies
- Promote efficient innovative methodologies and optimal
development plan
- Contribute to strategies for statistics related technologies,
processes, and standardsPOSITION ACCOUNTABILITIES:
- 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
as appropriate.
- 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
activities.
- Identify and interact with external statistical experts for
issues related to design, methodology and results as the primary
contact and spokesperson.
- Leverage scientific expertise for strategic statistical
leadership by providing recommendations and statistical
consultations to management
- 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
procedures
- Strong collaborative skills and ability to work with a
cross-functional team -
- 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
regulatory submissions.
- Excellent oral and written communications skills.
- Expertise in statistical programming, modeling and
simulationsWHAT 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.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, Salem , GI Statistics - Sr Manager, Executive , Salem, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...