Clinical Biomarker Data Scientist
Company: Takeda Pharmaceutical
Posted on: January 27, 2023
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Clinical Biomarker Data Scientist
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a
Clinical Biomarker Data Scientist in our Cambridge, MA
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
As a Clinical Biomarker Data Scientist working on the Preclinical
and Translational Sciences team, you will be empowered to work with
stakeholders within BST, PTS, and with partners in Data Sciences
Institute, Clinical Data Solutions, and Takeda's data initiative
team to support clinical biomarker data management and operational
- Ensure the quality of the translational biomarker data
generated from clinical studies.
- Responsible for all aspects of the clinical biomarker data
management process from data transfer from CROs to Takeda data
repository, to releasing reconciled data to data users
- Be a primary Biomarker Data Management contact for all
gastroenterology, neuroscience, and rare disease studies. Ensure
all biomarker data management activities are conducted in
accordance with GCP, Takeda SOPs, and regulatory requirements.
- Oversee the transfer of clinical biomarker data from biomarker
CROs to a centralized Takeda data repository including the
completion of Data Transfer Specifications and Agreements.
- Perform biomarker data integrity check and resolve queries with
- Coordinate internal scientific reviews of transferred raw
biomarker data and document review completion.
- Integrate clinical biomarker data sets with clinical EDC data
for downstream biomarker data analysis.
- Collaborate with Clinical Operations, clinical CRO, specialty
and central laboratories to resolve sample and data reconciliation
issues and maximize the quality of translational biomarker
- Collaborate with Clinical Sample Managers to design a seamless
process from sample management to data management.
- Participate in initiatives around data hosting and suitability
of various databases for biomarker data from different
- Coordinate with internal and external resources to ensure
timely delivery of data per study timelines
- Represent the department in discussions around the future of
clinical data handling at Takeda POSITION ACCOUNTABILITIES:
- Work with internal and external partners to develop processes
and workflows for data flows, data mapping, data security and data
- Work with data standards, data management, biostatistics, and
other key stakeholders to maintain and update existing biomarker
data standards for clinical trial studies.
- Work with clinical teams to provide controlled terminology and
mapping instructions for clinical biomarker data.
- Work with Translational Lead Scientists and Bioassay Scientists
to develop data transfer specification documents that ensure
complete and accurate delivery of clinical biomarker data.
- Interface with clinical project teams to mitigate issues with
clinical biomarker data standards.
- Interface with vendors to mitigate issues with clinical
biomarker data transfers, security, and reporting. EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS:
- BS, MS, or PhD in health-related, life science area or
technology-related fields. BS (14+), MS (9+) and PhD (6+) years of
clinical data management experience in a CRO,
biotech/pharmaceutical, or academic setting
- Technical knowledge to maintain and transfer electronic files
through sFTP, APIs, etc.
- Provides guidance and oversees data flow from internal and
external data platforms.
- Experience in regulatory and quality standards around data
- An understanding of biomarker assay platforms (NGS, IHC, Flow
Cytometry, etc.), and the types of data generated from such
platforms, is highly desirable.
- Familiarity and experience with handling clinical data sets,
clinical data standards (e.g. CDISC, SDTM) and related industry
- Working knowledge of SAS and familiar with other scripting
- Demonstrated understanding of the nature of research and
research environment with knowledge of data and standard practices
in the pharmaceutical industry.
- Demonstrated experience in managing clinical biomarker or
bioassay data, preferably in oncology studies.
- Working knowledge with Electronic Data Capture (EDC)
database(s). Base Salary Range: $137,200- $196,000, based on
candidate professional experience level. Employees may also be
eligible for Short Term and Long-Term Incentive benefits as well.
Employees are eligible to participate in Medical, Dental, Vision,
Life Insurance, 401(k), Charitable Contribution Match, Holidays,
Personal Days & Vacation, Tuition Reimbursement Program and Paid
Volunteer Time Off.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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 Programs Empowering Our People to Shine
Discover more at
No Phone Calls or Recruiters Please.
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.
Keywords: Takeda Pharmaceutical, Boston , Clinical Biomarker Data Scientist, Healthcare , Boston, Massachusetts
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