David Maislin

David Maislin Email and Phone Number

President and CEO at Biomedical Statistical Consulting LLC @ Biomedical Statistical Consulting®
David Maislin's Location
Philadelphia, Pennsylvania, United States, United States
David Maislin's Contact Details

David Maislin work email

David Maislin personal email

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About David Maislin

I am the President and CEO of Biomedical Statistical Consulting LLC (BSC), a best-in-class contract research organization supporting Regulatory clinical trials, Investor Initiatives, and Academic Projects.BSC specializes in human trials of medical devices – particularly orthopedic devices – and biologicals. The firm was founded in 1986, and I am the second generation building on the company’s legacy while ensuring we stay on the leading edge of theory and practice. I have served all roles in the company, from database manager, statistical analyst, and statistician to leading day-to-day operations alongside my biostatistical duties.My extensive experience in supporting Sponsors at all phases of developing regulated medical devices and pharmaceuticals has allowed me to develop advanced statistical analysis skills. I am an experienced statistician with a strong background in data analysis and clinical trial design. My particular interests include but are not limited to health-related Bayesian methods, simulation methodology, Propensity Score Matching, and using historical data.I have considerable experience in research design, report writing, presenting, and publishing. My co-authored work on orthopedic devices and sleep apnea has been published in top journals, including Quantitative Imaging in Medicine and Surgery, Journal of Spine & Neurosurgery, and Sleep. I am the trusted point of contact for hundreds of clients, advisor partners, and academic researchers. This is extremely rewarding, and I take pride in being able to deliver results. Clients understand they only receive unmatched experience, innovation, and reliability, whether they are looking for routine analysis, help to resolve complexities in a clinical trial, or need statistical representation in regulatory interactions.

David Maislin's Current Company Details
Biomedical Statistical Consulting®

Biomedical Statistical Consulting®

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President and CEO at Biomedical Statistical Consulting LLC
David Maislin Work Experience Details
  • Biomedical Statistical Consulting®
    President And Ceo
    Biomedical Statistical Consulting® Jan 2024 - Present
    Philadelphia, Pa, Us
  • Biomedical Statistical Consulting®
    Principal Biostatistician And Managing Partner
    Biomedical Statistical Consulting® May 2023 - Jan 2024
    Philadelphia, Pa, Us
  • Biomedical Statistical Consulting®
    Biostatistician | Vp Operations And Strategy
    Biomedical Statistical Consulting® Dec 2020 - May 2023
    Philadelphia, Pa, Us
    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.
  • Biomedical Statistical Consulting®
    Biostatistician
    Biomedical Statistical Consulting® Jan 2019 - Dec 2020
    Philadelphia, Pa, Us
    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.
  • Biomedical Statistical Consulting®
    Biostatistical Analyst
    Biomedical Statistical Consulting® Jan 2014 - Jan 2019
    Philadelphia, Pa, Us
    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.
  • Biomedical Statistical Consulting®
    Data Manager
    Biomedical Statistical Consulting® Jan 2013 - Dec 2013
    Philadelphia, Pa, Us
    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.
  • Approved Statistics℠, Llc
    Founder
    Approved Statistics℠, Llc Jun 2023 - Present
    Philadelphia, Pa, Us
    Statistics, approved for use.℠
  • Penn Medicine, University Of Pennsylvania Health System
    Biostatistician
    Penn Medicine, University Of Pennsylvania Health System Apr 2021 - Present
    Philadelphia, Pa, Us
    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.
  • Penn Medicine, University Of Pennsylvania Health System
    Biostatistical Analyst
    Penn Medicine, University Of Pennsylvania Health System Feb 2016 - Mar 2021
    Philadelphia, Pa, Us
    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.
  • Commercial Motor Vehicle Driver Restart Study
    Statistical Consultant
    Commercial Motor Vehicle Driver Restart Study 2015 - 2016
    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.

David Maislin Education Details

  • Penn State University
    Penn State University
    Statistics
  • Wharton Online
    Wharton Online
    Business Foundation Specialization
  • Penn State University
    Penn State University
    Bachelor Of Science - Bs

Frequently Asked Questions about David Maislin

What company does David Maislin work for?

David Maislin works for Biomedical Statistical Consulting®

What is David Maislin's role at the current company?

David Maislin's current role is President and CEO at Biomedical Statistical Consulting LLC.

What is David Maislin's email address?

David Maislin's email address is da****@****enn.edu

What schools did David Maislin attend?

David Maislin attended Penn State University, Wharton Online, Penn State University.

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