We are an innovative global diagnostic company with one purpose: to chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world. Our mission-driven culture is fueled by the embodiment of five core values permeating across the company—innovation, patient centricity, accountability, continuous improvement, and a culture built by collaboration and a can-do attitude.
KEY SKILLS:
Biostats + programming background.
SAS or R, preferably both
Well versed in technology – someone who has a niche of understanding the study.
Worked on clinical data, understanding edit checks and true queries
Biomarker capability
General Description
We are seeking a highly motivated, experienced and skilled biostatistician with solid experience in the diagnostics industry to fill the critical role of Biostatistician. The position is responsible for applying statistical techniques to the discovery of biomarkers, to play a key role in the development/validation of Company products in solid organ transplantation, contribute to analyses and text for peer-reviewed papers describing clinical trial and registry studies and assist transfer of assays from R&D to CLIA laboratory. This is an interactive and responsible position having key interfaces beyond R&D with personnel involved in clinical research, clinical informatics, commercial laboratory operations, instrument automation, manufacturing, engineering, and software development.
Responsibilities as follows, but not necessarily limited to:
- Contribute statistical expertise and guidance to studies conducted by the clinical, research, development, and clinical reference laboratory groups
- Gene expression profiling analyses
- Cell-free DNA test development using next-generation sequencing technologies
- Diagnostic test quality control development and test system statistical monitoring
- Clinical study design and analysis including detailed sample selection from existing archives and design of de novo studies
- Design and support multivariate gene expression diagnostic algorithms
- Provide support using established statistical tools
- Contribute to the development of automated biostatistical analysis pipelines for staff with different levels of understanding of biostatistics
- Contribute to regulatory submissions and responses
- Play a role in experimental, registry and trial design data analysis in support of internal and sponsored publications
- Statistical analysis including analysis of complex genomic data sets, validation studies, discovery and development studies
- Consult with research and development labs, commercial lab and clinical development and recommend appropriate experimental design methods and statistical techniques
- Provide basic statistical instruction for staff
- Review statistical approaches described in pertinent high impact peer-reviewed papers
Qualifications
- Ph.D. in statistics, mathematics, computational methods, or a related discipline or equivalent experience. Additional training or degree in biochemistry, molecular biology, or immunology would be considered an added benefit.
- Minimum 8-10 years experience working in the in vitro diagnostics field (LDT and/or FDA regulated)
- In-depth familiarity with established statistical tools (survival analyses, sensitivity, specificity, accuracy, NPV, PPV, AUC (ROC), etc.)
- Interest in emerging diagnostic statistical tools (Bayes pre- and post-test probability, reclassification indices, etc.)
- Expert in R, SAS and other statistical software packages
- Experience in analysis of high-throughput next-generation sequencing and gene expression data (e.g. microarrays, RNA-Seq, etc.)
- Experience using diverse and fit-for-purpose experimental design techniques required
- Strong desire and proven ability to work collaboratively and cross functionally on new product development teams, departmental projects, and company initiatives
- Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains.
- Solid problem solving skills
- Strong presentation skills