Senior Manager, Statistics
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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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
- 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
- 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 ProgramsPHYSICAL 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 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, Paterson , Senior Manager, Statistics, Executive , Denville, New Jersey
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