Senior Manager, Statistics
Company: Takeda Pharmaceutical
Location: East Norwich
Posted on: May 13, 2022
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.
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, 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
complex programs.
Providing strategic statistical input for feasibility assessments,
development plans, cross-study analyses and regulatory
submissions.
Improving and using standards to maximize global data
integratability, interpretability and compound level
efficiency.
Leveraging internal and external resources to achieve quality,
timely and cost-effective compound level and submission
deliverables.
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
programs.
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 deliverables.
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
improvements.
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
documents.
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
products).
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
Plan
Tuition reimbursement
Relocation Assistance
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 Programs
PHYSICAL DEMANDS:
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this job. - Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions.
Ability to sit and stand for long periods of time.
Carrying, handling and reaching for objects.
Ability to lift and carry over 25 pounds.
Manual dexterity to operate office equipment i.e. computers,
phones, etc.
TRAVEL REQUIREMENTS:
Access to transportation to attend various meetings held in
proximity to the Takeda offices.
Able to fly to various meetings at investigator, vendor or
regulatory agency sites.
Some international travel may be required.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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.
EEO Statement
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 Pharmaceutical, New Rochelle , Senior Manager, Statistics, Executive , East Norwich, New York
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