The Sr. Biostatistician at Spectral MD is responsible for developing clinical study designs for a novel imaging technology that uses artificial intelligence algorithms to diagnose disease. This role will work with a team of doctors, scientists, and engineers to characterize and validate this device in multiple clinical applications. The position is responsible for the statistical design and analysis of clinical studies as well as communication of results to project sponsors and the FDA. We are seeking someone with a strong background in clinical study design, diagnostic device characterization, and preparation of clinical study reports.
Work within a team for protocol development
Recommend statistical analysis methods to achieve clinical study objectives
Perform power calculations for proposed study designs
Write statistical analysis plans and reporting specifications from simple to complex clinical studies
Lead the study teams in the review, and discussion, of analysis plans
Estimate the time and cost of clinical studies under various scenarios
Contribute to CRF design and database edit checks
Using statistical software to carry out statistical analysis plans
Explain results to internal teams, project sponsors, senior management, and the FDA in written and oral communication
Maintain project files that ensure adequate and clear documentation of statistical analyses according to quality system requirements
Analyze clinical study data to identify factors (e.g., confounding covariates) that influence device effectiveness
Oversee statistical deliverables to ensure compliance in timing and quality
About 10% travel would be required
MS or Ph.D. in Statistics, Biostatistics, Applied Mathematics, or comparable experience.
Candidates must demonstrate they have a background in the following:
At least 5+ years of post-graduate industry or academic experience in clinical study design for medical imaging or diagnostic devices
Demonstrated knowledge of device assessment including:
hypothesis testing of diagnostic test accuracy;
generalized linear mixed models;
ROC curve analysis;
sample size calculations;
methods to handle missing data;
exploration and confirmation of confounding covariates;
corrections for experimental biases (e.g., verification bias); and
knowledge Bayesian approach to modeling is desirable.
Strong written and oral communications skills
Demonstrated history of writing manuscripts, technical papers or abstracts
Ability to create presentations and present results to cross-functional stakeholders
Demonstrate experience as primary author of statistical analysis plan for an IRB reviewed clinical study design
Demonstrate experience as primary author of study analyses that were reported in a pre-market submission to the FDA-CDRH or in a peer-reviewed publication
Solid experience in a statistical programming language
Able to work in a fast-changing environment
Experience with Bayesian hypothesis testing and adaptive clinical study design would be a plus
About Spectral MD
Spectral MD, a mid-stage medical device company, is developing a diagnostic imaging device from visible and infrared images of burns, chronic wounds, and other pathological conditions of the skin. We focus on image processing and machine learning of digital biological images to help clinicians make better and faster treatment decisions. Preliminary clinical studies are running in multiple applications of the device, especially: burn wound diagnosis; diabetic foot ulcer assessment; and lower extremity amputation site selection. Spectral MD is located in a modern high-rise office building in the heart of Uptown Dallas, TX.
Spectral MD, a mid-stage healthcare company, is developing a diagnostic device from visible and infrared images of burns, chronic wounds, and other pathological conditions of the skin. We focus on image processing and machine learning of digital biological images to help clinicians make better and faster treatment decisions. Spectral MD is located in a modern high-rise office building in the heart of Uptown Dallas, TX.