Basic Function and Scope of the Position:
The Biostatistician will act as a lead analyst working on data related to the development of clinical assays in a CLIA/CAP laboratory. The successful candidate will possess strong statistical and analytic skills, solid programming experience, and a high level of professional maturity.
Tasks and Responsibilities:
- Provide statistical guidance and perform analyses that enhance Applied Proteomics’ multiple-analyte clinical assays. Develop a deep understanding of Applied Proteomics’ tests. Serve as a key computational resource to propose and evaluate methods in the Product Research and Development laboratory.
- Design and analyze development, verification, validation, and other studies using DOE approaches.
- Design and execute analyses to assess experimental factor effects and quality-related measures in the laboratory. Perform ongoing monitoring of assay measures and outcomes. Proactively explore the data to uncover elusive problems and ensure high-quality tests.
- Perform other statistical analyses as needed. This may include machine learning to build classifiers for clinical tests.
- Develop software to perform these analyses. Contribute to documentation and testing of production‐level computational software.
- Clearly summarize technical findings in oral, written, and graphic forms for internal and external scientific colleagues.
- Collaborate with a team of laboratory scientists, bioinformaticians, regulatory affairs specialists, and quality assurance specialists.