Associate Director, Statistics, PRO and Benefit-Risk Assessment
Company: Takeda Pharmaceutical
Posted on: September 22, 2022
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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 an Associate Director, Statistics, PRO &
Benefit-Risk Assessment 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:The
Associate Director is responsible for assisting the Director,
Statistics with management and leadership of biostatistics-related
activities in the area of Patient Reported Outcomes (PROs), other
clinical outcome assessments, and benefit-risk assessment.
Contributes to PRO and benefit-risk strategy, and serves as a
statistical expert in registration and communication activities.
Represents Takeda and provides input to his/her supervisor for
statistical issues in communications with regulatory authorities.
Reviews regulatory documents such as protocols and Clinical Study
Reports, as well as summary documents.POSITION
- Provides leadership in biometrics activities pertaining to
study projects. - Collaborates with project teams on design and
analysis of clinical trials; selects appropriate statistical
methods for design of clinical trials and the analysis of clinical
study data; provides input into clinical development plans.
- -Contributes to PRO section of protocol and SA. Reviews
statistical outputs. Primary author of the PRO section of study
reports for study and integrated reports.
- Contributes to structured benefit-risk documents. Applies
methods such as multi-criteria decision analysis (MCDA).
- Responsible for interacting with regulatory authority personnel
on clinical trial statistical issues in the design, analysis of
clinical trials, design of other study types, and data
- Reviews regulatory documents such as CSRs, as well as summary
- Consults with the Medical Writer and Physician on the
interpretation of PRO results and the outputs of benefit-risk
analysis. Contributes to the publication plan. - Reviews abstracts,
posters, and manuscripts to support Medical Affairs.
- Leads or contributes to departmental process improvement
initiatives and development/revision of SOPs.
- Contributes to the establishment and maintenance of common
formats and templates for key Biometrics documentation (e.g.,
statistical section of protocol, standard CRF pages, Statistical
Analysis Plans, Tables, Figures and Listings). Contributes to the
design of standards for SAPs.
- Directs outsourcing activities in collaboration with preferred
vendors. - Provides strategic and tactical input in the contracting
with Statistical & Quantitative Sciences (SQS) preferred
providers.CORE ELEMENTS RELATED TO THIS ROLE:
- Strong background and working knowledge of statistical methods
that apply to all phases of clinical trials and other study
designs. Must have a working knowledge of statistical analysis
plans including the report outline, mockup tables, graphs and data
listing shells and appendices.
- Must have a working knowledge of all appropriate relevant
regulatory guidance documents (e.g. ICH, FDA and EMEA).
- Direct regulatory filing experience is required.
- Proficiency in SAS is strongly preferred. Proficiency in R is
- Experience with PROs and other clinical outcome assessments in
clinical trials is -preferred.
- Experience with -benefit-risk assessment techniques such as
MCDA is -desired.
- Ability to help others understand the broader business and
organizational context (inspiring and motivating others)
- Demonstrated ability to deliver excellence by integrating
planning efforts across departments or organizational boundaries to
ensure organizational effectiveness (delivering excellence)
- Demonstrates a customer focus by partnering with customers as a
trusted consultant and serves as an integral part of customer's
decision-making process (serving customers)
- Demonstrated ability to reinforce a culture in which partnering
is a norm (global and cross-boundary communication)
- Demonstrated ability to accept responsibility for individual
and team performance (accountability & ownership)
- Demonstrated ability to evaluate the business impact of
decisions and remains committed to following through on agreed upon
decisions yet remains flexible should priorities change (judgment
and decision making)Complexity -
- Ability to determine appropriate designs and analyses for
- Ability to respond to regulator's inquiries for products
undergoing registration and approved products.
- Ability to take appropriate action in all dealings with CRO
partners to ensure that best practices are followed.EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS:
- M.S. in Biostatistics or closely related field is
- Ph.D. in Biostatistics or closely related field is strongly
- Generally has 8+ years of relevant pharmaceutical
experience.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- 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.This posting excludes Colorado applicants.This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy.#LI-SGMEEO 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, Trenton , Associate Director, Statistics, PRO and Benefit-Risk Assessment, Executive , Califon, New Jersey
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