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Job Description

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 location.

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.

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 processes.

POSITION OBJECTIVES:

• 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 biomarker CROs.
• 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 data.
• 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 modalities
• 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 QC.
• 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 requirements.
• 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 standards.
• Working knowledge of SAS and familiar with other scripting languages
• 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 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 Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

• KB-LI

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.

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