Senior Manager, Statistics
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 11, 2022
Job Description:
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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, 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:Takeda is a global, values-based,
R&D-driven, top 10 biopharmaceutical leader committed to
discover and deliver life-transforming treatments, guided by our
commitment to patients, our people and the planet.Our Data Sciences
Institute (DSI) is made up of more than 250 quantitative scientists
who harness the insight of data and digital to speed the
development of highly innovative treatments to patients. These
scientists (from statistics, programming, outcomes research and
epidemiology, quantitative clinical pharmacology, digital strategy,
library sciences and data architecture/governance) bring their
expertise to our global program teams and re-imagine our
disciplines. They work with novel data streams, including
real-world data and digital tools, and apply advanced analytics
including artificial intelligence and automation.As part of DSI,
the Statistics and Quantitative Sciences (SQS) at Takeda is looking
to add individuals to our team that are team oriented,
collaborative, strong understanding of the statistical programming
function, exceptional leaders and innovators. SQS aspires to bring
safe and effective medications to the patients with our
quantitative skills. We design efficient trials, contribute to
clinical development strategies, perform high quality statistical
analyses, and pursue operational excellence.To attract and retain
the very best talent, we in Takeda SQS are open to flexible or
remote working for some roles. Such roles will have a connection to
a Takeda R&D center.POSITION ACCOUNTABILITIES:
- Lead project delivery directly related to global project teams
or other functions
- Work independently and prioritize delivery for projects cross
functionally and with vendors
- Effectively drive and influence project teams towards seamless
delivery while enabling and making decisions
- Contribute to asset level strategies to identify and mitigate
delivery risks
- Have internal and external presence on delivery risks and
enabling risk mitigation actions
- Have the ability to implement process and best practice changes
through effective delivery risksCORE ELEMENTS RELATED TO THIS ROLE:
- 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.
- Strong statistical programming skills
- Excellent oral and written communications skills.
- Specialized statistical expertise in multiple therapeutic areas
or development phases.
- Strong project management skills.
- Strong collaborative skills and ability to work with a
cross-functional team.
- Independently represent Data Science function on projects
leading data strategies related to diseases, assets or other areas
of interest in Takeda's ecosystem.
- Play a leadership role in the development and review of data
science projects and their respective strategies, spanning
spontaneous data exploration in individual data sources to designed
and planned studies requiring the synthesis of many data
archetypes.
- Perform beginning-to-end data analyses, from data strategy to
objective formulation, to data exploration and insights, to
hypotheses formulation, experimental design, writing analysis
plans, data cleaning and curation, executing analysis, to
interpretation and preparing reports with documentation.
- Develop and support optimal data handling and data provenance
practices utilizing reproducible, interpretable data research
approaches
- Strengthen Takeda's advanced analytics toolkit by identifying
and applying emerging innovative techniques, as well as by
advancing the state of the art and developing novel analysis tools
as needed.
- Collaborate effectively within a matrix environment with
business leaders and scientists to identify and develop appropriate
goals for data science work (for example identifying sensitive and
specific endpoints for segmenting patient population, tracking
disease progression, quantifying quality of life, etc.). Partner
with colleagues from a multitude of functions that span R&D
(e.g., pharmacology, chemistry, imaging, translational sciences,
computational biology, experimental medicine) to Commercial
(patient services, sales and marketing, medical information).
- Provide thought leadership in concepts related to data
acquisition and ingestion working with Data Architecture and IT.
Understand respective systems security and provide support for data
transparency, disclosure, and governance. Strategically connect
with Takeda enterprise projects related to the Digital Advisory
Board and the Global Data Council.
- Work closely with Takeda statisticians and other quantitative
experts to ensure statistical issues in data analysis are addressed
as needed.
- Anticipate and communicate internal and external resource and
quality issues that may impact deliverables or timelines of the
program. Propose and implement solutions. Escalate issues to
management as appropriate in a timely manner.
- Increase the internal impact of Takeda's data science work by
identifying opportunities across therapeutic or disease areas and
business units.
- Increase the external recognition of Takeda's data science work
by participating in conferences, publishing work and developing
external collaborations
- Serve as global statistical lead for biomarker development in
Oncology TA.
- Play a leadership role in development and completion of major
statistics deliverables and milestones in collaboration with other
functions.
- Drive/participate in development and implementation of global
systems, processes and standards to maximize quality and
efficiency.
- Leverage standardized analysis methods and reporting standards
to maximize global data integrability; identifies best practice for
utilization across programs.
- Provide statistical leadership and support for internal
decision making, regulatory meetings, submissions and follow
up.
- Provide or identify internal and external statistical expertise
and capacity to support development activities.
- Collaborate/lead in the development of compound/program-level
sourcing/vendor strategies and provide oversight of statistical
services, ensuring overall quality.
- Assess, communicate and propose solutions for internal,
external resource and/or quality issues that may impact
deliverables/timeline at the program level.
- Provide input for planning and management of external budgets
related to statistical deliverables.
- Participate/Leads in external professional initiatives and
organizations such as ASA, PhRMA, DIA, etc. to identify industry
best practice and its applicability in TakedaDIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise
- The capability to gain broader technical expertise outside of
primary area
- The ability to communicate effectively with cross functional
teams and explain statistical and quantitative concepts to
non-experts
- The drive for learning techniques and methods and also for
continuous improvement through various avenues of the
organizationLeadership
- Lead projects directly or indirectly related to Global ProJet
Teams (GPTs) or other functions
- Work independently and prioritize projects
- Effectively drive and influence project teams towards
objectives while enabling and making decisions
- Contribute to asset level strategies
- Have internal and external prescience on topics of
interestEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- PhD with -3+ years experience in statistical or quantitative
field
- MS with -6+ years experience.WHAT 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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.#LI-SGM
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, New Rochelle , Senior Manager, Statistics, Executive , Bronx, New York
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