David S. Email & Phone Number

Seattle, Wa, Us

Lawrence Township, Nj, Us

o Statistical representative on global project team tasked with developing an integrated development plan (multiple indications)o Statistical lead for life-cycle management of Zeposia (approved for multiple sclerosis)o Statistical lead for small molecule oncology drug repotrectinib (Phase 3, ROS1 non-small cell lung cancer and NTRK+ solid tumor, submitted in US, EU and Japan)o Statistical lead for compound entering late-stage development with dermatology indications including psoriasiso Statistical lead for discontinued GI indications (ulcerative colitis, Crohn’s disease)Accomplishments include:o Developing a pediatric study with a strong Bayesian prior that is currently enrollingo Integrated and transitioned a heritage team (from an acquisition) into BMS ways of working and SOPso Planned and developed GO/No GO strategy with Bayesian evaluation of likelihood of success based on results of Phase 2o Evaluating and advising outside partner attempting to build a tool to use AI to help automate production of Clinical Protocols and Statistical Analysis Planso Deployment of a tool to automate production of CRFs based on a standard template for Clinical Development Plans and Clinical Protocols

Marlborough, Ma, Us

North Chicago, Illinois, Us

• Supervise clinical data management group responsible for EDC system• Design, implement and analyze clinical trials for in-vitro diagnostic devices• Assist Regulatory Affairs during pre and post-submission communications with FDA• Design adaptive trials for diagnostic directed (CoDX) intervention• Assist and advise R&D during assay development• Implement and analyze a broad range of statistical techniques, including hierarchical and mixedrandom effects models (Bayesian and frequentist) and time-to-event/hazard/survival models• Direct and mentor other statisticians

• Design and implement adaptive Bayesian clinical trials for oncology, drug and therapeutic device applications.• Advise clients how to address FDA concerns and work with the FDA on modification of protocols. • Prepare final data reports for submission to FDA.• Participate in client conferences with FDA. • Create framework for large-scale cloud-based distributed computations (Amazon EC2).• Write software modules implementing adaptive randomization and monitoring for use by CROs.• Write own software for calculating, simulating and reporting trial designs and analyses in R/Splus, Fortran90/2003, Perl and bash.• Work with clients on a variety of other statistical projects, including evaluating diagnostic tests and device certification regimens.

Houston, Tx, Us

• Develop new techniques for analysis of high-throughput gene expression and comparative genomic hybridization microarray assays.• Work with physicians and researchers to analyze and interpret high-throughput microarray assay data.• Participate in clinical trial design reviews. • Write software for analysis and management of data in R/Splus, Perl and SQL.

Houston, Texas, Us

• Carry out research in statistical, human and forensic genetics.• Teach graduate courses in statistics and statistical genetics.