- The successful candidate will serve as an expert scientific and functional team member in the Translational and Biomarker Statistics. In this role, you will have the opportunity to be closely engaged in developing biomarker objectives for clinical projects and influencing and the development of companion diagnostics (CDx).
Key Responsibilities include, but are not limited to:
• Engage with project CDx team and provide direction and input to ensure high quality and timely support for the various CDx biomarker projects across all phases of drug development in collaboration with other functional area scientists.
• Propose and implement optimal and fit-for-purpose statistical and computational solutions for various biomarker and CDx product development, including:
o Assay Validation [e.g. multiplex ELISA, omics (NGS, microarray, Nanostring), Flow Cytometry, ELISpot, PCR]
o CDx bridging study design and analyses
o Pre-sub/PMA submission and regulatory interactions
• PhD in statistics, computational methods or related field with focus on methods for genomics and related high-dimensional data analysis.
• Prior experience in companion diagnostics and precision medicine, especially in supporting CDx development submission with bridging strategy
• Strong multi-tasking and self-management skills.
• Demonstrated ability to apply innovative and fit-for-purpose statistical and predictive modelling methods for the analysis of biomarker data from clinical trials.
• Excellent interpersonal communication skills, with a proven track record of building and maintaining strong working relationships.
• Excellent written and oral ability to explain novel and standard methods to scientific and clinical colleagues.
• Experience with a wide variety of biomarker data such as genomics, proteomics and imaging from various traditional and cutting-edge analytical platforms in oncology and/or other therapeutic areas.
• Background in biological sciences, bioinformatics and computational biology.
An analytical and inquisitive mind with a proven track record for proble
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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