Senior Manager, Statistics
Company: Takeda Pharmaceutical
Location: East Orange
Posted on: May 14, 2022
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, - in our Cambridge
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.OBJECTIVE:The purpose of
this position is to provide compound level / development phase
statistical expertise and leadership by:
- Independently designing, analyzing and interpreting clinical or
observational studies at a compound level for early phase or less
- Providing strategic statistical input for feasibility
assessments, development plans, cross-study analyses and regulatory
- Improving and using standards to maximize global data
integratability, interpretability and compound level
- Leveraging internal and external resources to achieve quality,
timely and cost-effective compound level and submission
- Independently representing Statistics function in interactions
with regulatory authorities.ACCOUNTABILITIES: -
- Independently represent statistics function on global teams in
support of clinical or observational studies and compound level
- Provide strategic statistical input to feasibility assessments,
development and submission plans, and defense of regulatory
submissions. Negotiate timelines (statistical) at compound level.
- Plays a leadership role in the development and review of the
study synopsis, protocol, statistical analysis plan, study report,
and other regulatory submission documents, ensuring accurate and
statistically valid deliverables.
- Oversee definition and implementation of compound-level
database (including derived database), analysis and reporting
standards. - Improve or use existing standards to ensure
maximization of global integratibility and interpretability of data
and enhance efficiency at compound level. - Coordinate with Data
Management, Programming, Clinical and PV to target high quality
databases and specifications at compound level.
- Plan and direct compound level analysis and reporting
activities (eg, tables, listings, graphs) including work of other
statisticians and programmers.
- Identify compound level vendor requirements and participate in
the evaluation/selection of vendors. Provide compound level
analytical oversight of statistical activities of external vendors
to ensure timeliness and quality of analysis data and statistical
outputs. Review and approve key statistical vendor
- Identify and interact with external statistical experts for
issues related to study design, methodology and results.
- Anticipate and communicate internal and external resource and
quality issues that may impact deliverables or timelines of the
compound level program. - Propose and implement solutions. Escalate
issues to management as appropriate in a timely manner.
- Lead the implementation of department standards and process
- Lead evaluation and implementation of alternative analysis
methodology and data presentation techniques.
- Monitor and contribute to industry advances in statistical
methods to optimize study designs and statistical analysis methods,
and implement innovative approaches at a compound level.EDUCATION,
EXPERIENCE AND SKILLS: -
- PhD in statistics or biostatistics with at least 3 years of
relevant experience or MS in statistics or biostatistics with at
least 6 years of relevant experience..
- Experience with advanced study design or at least one NDA/CTDs
or other global regulatory submissions.
- Advanced knowledge of clinical or observational study designs,
common analysis methods, descriptive and inferential statistics.
- Advanced knowledge of the pharmaceutical industry including
understanding of clinical drug development process and associated
- Extensive knowledge of FDA and ICH regulations and industry
standards applicable to the design, analysis of clinical trials or
observational research, and regulatory submissions.
- Good knowledge of statistical programming languages (including
SAS), software, techniques, and processes. Working knowledge of
UNIX operating systems, and common software products and
technologies used in conjunction with SAS (e.g., Microsoft Office-'
- Excellent oral and written communications skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a
cross-functional team.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Relocation Assistance
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- Empowering Our People to ShineEEO 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.LocationsLexington,
MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, East Orange , Senior Manager, Statistics, Executive , East Orange, New Jersey
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