David Maislin

As a Biostatistician, my primary responsibility is Designing and Analyzing Clinical Trials for Medical Devices and Biologics submitted to regulatory agencies. I am responsible for interacting with regulatory agencies on behalf of Sponsors and closely collaborating with Sponsors and their partners. I use Bayesian and Frequentist methods and develop novel algorithms and simulations for Adaptive designs, longitudinal data analysis, complex CT and MRI data, missing data, and survival data. As Vice President of Operations and Strategy, I lead day-to-day management across company initiatives and oversee regulatory compliance requirements and continuous improvement processes. An important responsibility of my job is to curate and cultivate strategic partnerships.

As a Biostatistician, my primary responsibility is Designing and Analyzing Clinical Trials for Medical Devices and Biologics submitted to regulatory agencies. I am responsible for interacting with regulatory agencies on behalf of Sponsors and closely collaborating with Sponsors and their partners. I use Bayesian and Frequentist methods and develop novel algorithms and simulations for Adaptive designs, longitudinal data analysis, complex CT and MRI data, missing data, and survival data.

Data processing and statistical analysis for multiple ongoing projects for hundreds of Sponsors primarily focused on the support of FDA submissions. Worked collaboratively with Biostatistical and analytical teams, and interacted with Sponsors and Regulatory consultants. Primary responsibilities included statistical analysis of randomized multi-center US and OUS Clinical Trials, conducting statistician-specified statistical hypothesis testing and estimation for continuous and categorical outcomes, survival endpoints, mixed model analyses of repeated measures, and meta-analysis. Developed and performed analysis plans using Bayesian Hierarchical modeling and specialized data visualization.

Responsible for creating an SOP-governed clinical database and providing quality assessments supporting the randomized clinical trial sponsored by the Memorial Hermann Health System concerning methods to place peripherally inserted central catheters.

Statistics, approved for use.℠

Perform statistical analysis and communicate results to clinical stakeholders including National Institute of Health (NIH) funded clinical trials. Develop algorithms to synchronize high-frequency cardiovascular data to support personalized medicine and telemedicine ventures. Maintain and improve existing and developing databases. Build automated reporting platforms using Multiple API streams.

Perform statistical analysis and communicate results to clinical stakeholders including National Institute of Health (NIH) funded clinical trials. Develop algorithms to synchronize high-frequency cardiovascular data to support personalized medicine and telemedicine ventures. Maintain and improve existing and developing databases. Build automated reporting platforms using Multiple API streams.

A congressionally mandated study conducted by the Federal Motor Carrier Safety Administration (FMCSA). Developed innovative programming to integrate data from 235 CMV drivers followed for up to five months including more than 79,000 PVT-B performance tests and driver reported outcomes and other safety endpoints. Using driver electronic log data (ELD) as input, developed a sophisticated ELD sampling unit identification algorithm based on Expansion Algorithms that partitioned ELD input data (date-times of driving, on-duty, off-duty, sleeper berth) into sampling units each consisting of one Restart period and one driving period in which every Restart period was categorized as including 1, 2, or >2 intervals spanning 1am to 5am. Developed extensive quality assessment and resolution strategies. Conducted extensive analysis of the data in collaboration with Principal Investigators.