Associate Director, Statistics, PRO and Benefit-Risk Assessment
Company: Takeda Pharmaceutical
Location: Scituate
Posted on: August 7, 2022
Job Description:
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 Privacy Notice and Terms of Use . I further attest
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 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
ACCOUNTABILITIES:
- 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
presentations.
- Reviews regulatory documents such as CSRs, as well as summary
documents.
- 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
desired.
- 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
clinical trials.
- 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
required.
- Ph.D. in Biostatistics or closely related field is strongly
preferred.
- Generally has 8+ years of relevant pharmaceutical
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 No 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. 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, Boston , Associate Director, Statistics, PRO and Benefit-Risk Assessment, Executive , Scituate, Massachusetts
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