Responsibilities
- Collaborate with wet lab scientists to design experiments and analyze both historical and experimental data.
- Perform quick and thorough analyses of DNA sequencing data to understand outliers, perform QC, make descriptive figures, and address key statistical questions.
- Lead the statistical analysis design process supporting IVD-level product and QC method development studies while adhering to appropriate regulatory guidance, including CLSI and Design Control.
- Independently write and contribute to study protocols, data analysis, and final reports in working with other scientists in the group.
- Facilitate consensus approval for development study protocols, coordinating input from various technical stakeholders to ensure statistical plans meet business needs and CLIA/CAP, ISO and FDA requirements.
- Utilize internal processes and tools that support efficient document writing and life‑cycle maintenance.
- Contribute to analysis of NGS immunosequencing data, requiring innovative methods for statistical analyses of complex big data generated through the experiments.
- Present results to diverse audience, including cross‑functional senior leadership, clinicians, and executives.
- Be a problem solver: communicate well, ask questions, proactively eliminate bottlenecks, and be the person people go to when they want a job done right.
- Perform other duties as assigned.
Requirements
- PhD and 5+ years of experience, or
- MS/MA degree and 13+ years of relevant experience.
- Proficiency in at least one common coding language (R, Python, etc.).
- Demonstrated ability to work on multidisciplinary teams.
- Experience in presenting technical material to diverse audiences.
Core Competencies
Demonstrates expertise in statistical analysis design and data interpretation, particularly in the context of IVD product development and regulatory compliance. Proficient in coding languages such as R and Python, with a strong ability to communicate complex data insights to diverse audiences.
