Biomarker Data Specialist Jobs

Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis and predictive modeling.

Experience in the application of bioinformatics methods and evidence to drug development

Contribute to departmental initiatives (e.g., infrastructure/ process-related or scientific activities)

Good understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting is a must

Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations.

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biotechnology industry is strongly preferred

4) Preference will be given to candidates with recent experience in clinical biomarker

Experience in global vendor/supplier qualification and management, issue investigation/resolution and risk management;

Ensure proper QA issue escalation with senior management and with external vendors;

Strong knowledge of clinical lab certification/accreditation, biomarker assay verification, assay validation, assay transfer, etc;

Extensive experience of CDx/IVD product development under Design Controls and knowledge of QMS design and implementation;

Establish and implement vendor/partner qualification and audit plan with risk-based approach to ensure compliance and proper diligence;

Experience in supporting regulatory submissions (e.g. IDE, 510k, PMA) and HA interactions from QA perspective;

Years of experience: 0 – 5 years; dependent on level of related skills and education

Effective time management skills and ability to prioritize successfully

Previous LIMS (Laboratory Information Management System) experience

Oncology experience and/or working knowledge

BA/BS in relevant field; years of experience may substitute for education

Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables