David H. Spruell, Ph.D.

Currently Unavailable For New Opportunities at Currently on sabbatical
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Contact Information
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(386) 825-5501
Location
Greater Philadelphia

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Nicholas Gross

David and I worked together at Cephalon. David was a statistical programmer and we worked together on a few projects. He was a great person to work with because of his programming, statistics, and communication skills. I highly recommend David as a statistical programmer or any related field.

LinkedIn User

I have got a chance to work with David while I was working with Octagon. David is a very nice, friendly and easy-going person. David’s sas programming skills are trusted and his leadership skills are excellent. I noticed that David is a highly dedicated person with detail in projects. He plays a very important role in project meetings. David completes his assignments with in timelines. I really liked his way of explanations in project related discussions. I highly recommend David’s experience in any organization.

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Credentials

  • Clinical Trials SAS Programming Certificate
    Philadelphia University
    Dec, 2003
    - Oct, 2024

Experience

    • Advertising Services
    • 1 - 100 Employee
    • Currently Unavailable For New Opportunities
      • Jun 2019 - Present

    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • SAS Programmer
      • Aug 2018 - Jun 2019

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • SAS Programmer II (Kforce Consultant)
      • Aug 2018 - Dec 2018

      • Pfizer Inc., Collegeville, PA August 2018-Present SAS Programmer II • Currently training on Pfizer’s Clinical Development Analysis and Reporting System (CDARS.) • Training on Linux and Citrix systems. • Training on leveraging both Linux and Citrix systems to access and navigate through directories relevant to data manipulation and reporting in SAS. • Pfizer Inc., Collegeville, PA August 2018-Present SAS Programmer II • Currently training on Pfizer’s Clinical Development Analysis and Reporting System (CDARS.) • Training on Linux and Citrix systems. • Training on leveraging both Linux and Citrix systems to access and navigate through directories relevant to data manipulation and reporting in SAS.

  • INC Research/inVentiv Health Clinical
    • Phoenixville, PA 19460 - Work from Home
    • Senior Statistical SAS Programmer and Independent Contractor for 7 years: 2010 - 2017
      • Jul 2017 - Dec 2017

      • Created a macro program to generate multiple table outputs: Adverse Events by Groups (e.g., relatedness, severity, etc.), Medical History, and Concomitant Medications. • Streamlined programs using SAS Macros for repetitive programming tasks to facilitate project requirements. • Adapted complicated vaccine research programs (Primary/QC) for reuse across new and/or ongoing studies. • Create and maintain programming tracking documentation. • Created, tested and maintained SAS programs for vaccine clinical studies. • Generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan. • Generate outputs and reports to support other departments. • Performed validation on computer-generated output to verify accuracy. • Followed departmental SOPs, Good Programming Practices, and relevant regulatory guidelines (e.g. ICH). • Leveraged time management skills to ensure that vendor deliverables were properly generated, or quality checked under significant time constraints across multiple studies. Show less

    • United States
    • Staffing and Recruiting
    • 700 & Above Employee
    • Senior SAS Programmer - Contractor
      • Nov 2016 - Jan 2017

      • Responsible for QC of vendor/CRO table deliverables. The methodology involved creation of table outputs directly from raw data that involved heavy reliance on protocol and SAP information. • Leveraged time management skills to ensure that vendor deliverables were properly QC’d under significant time constraints across multiple studies. • Contributed to ongoing improvement of programming processes and methodology via macro development. • Responsible for QC of vendor/CRO table deliverables. The methodology involved creation of table outputs directly from raw data that involved heavy reliance on protocol and SAP information. • Leveraged time management skills to ensure that vendor deliverables were properly QC’d under significant time constraints across multiple studies. • Contributed to ongoing improvement of programming processes and methodology via macro development.

    • Senior Statistical Programmer - Contractor
      • Oct 2013 - Feb 2015

      • Worldwide Clinical Trials, Inc., King of Prussia, PA Sr. Statistical SAS Programmer - Program Lead • Created Data Definition Specifications (DDS) following SDTM and ADaM CDISC standards. • Carried-out quality assurance by performing all activities in compliance with WCT and agreed sponsor quality system standards. Proactively liaised with Clients, Statistical Programmers, Project Managers, and Data Management to establish timelines to ensure all deliverables met or exceeded client requirements. • Developed and implemented process improvements as needed (e.g., quality control check-lists, macro development and validation, etc.) to improve the efficiency and quality of the clinical study data processing and reporting efforts. Show less

    • Senior Statistical Programmer - Contractor
      • May 2011 - Feb 2013

      • Wrote, modified, and maintained programs which produced complex safety datasets, tables, and listings from clinical trial data. • Ensured analysis data and statistical reports met both regulatory and company standards. • Performed QC activities for SDTM, ADaM and TLFs. • Produced data specifications for subsequent SDTM and ADaM dataset programming. • Developed efficient, well-documented SAS code using Base SAS and SAS/ Macro facility leveraging Good Programming Practices. • Wrote, modified, and maintained programs which produced complex safety datasets, tables, and listings from clinical trial data. • Ensured analysis data and statistical reports met both regulatory and company standards. • Performed QC activities for SDTM, ADaM and TLFs. • Produced data specifications for subsequent SDTM and ADaM dataset programming. • Developed efficient, well-documented SAS code using Base SAS and SAS/ Macro facility leveraging Good Programming Practices.

  • Allergan Medical Devices
    • Goleta, CA - Contractor
    • Principal Programmer - Contractor
      • Oct 2010 - Feb 2011

      • Used Proc Univariate to generate Wilcoxon Signed Rank Test statistics and Proc Means to determine Alpha Levels with corresponding lower and upper level confidence limits (i.e., LCLM/UCLM) for numerous statistical tables. • Generated statistics to QC Disposition, Adverse Events, Vital Signs, and Laboratory shift tables. • Developed SAS QC macro programs to identify raw data quality issues. • Used Proc Univariate to generate Wilcoxon Signed Rank Test statistics and Proc Means to determine Alpha Levels with corresponding lower and upper level confidence limits (i.e., LCLM/UCLM) for numerous statistical tables. • Generated statistics to QC Disposition, Adverse Events, Vital Signs, and Laboratory shift tables. • Developed SAS QC macro programs to identify raw data quality issues.

    • Japan
    • Biotechnology Research
    • 700 & Above Employee
    • Consultant and Program Lead for Shire’s First In-House Study - Contractor
      • Sep 2007 - Mar 2010

      • Served as Program Lead for Shire’s first in-house study using my self-built, flexible table macros programs to generate statistical output. Also, developed to check raw data for quality and accuracy. • Developed a Macro Program Library for all validated SAS table and utility programs. • Became an in-house expert in the creation of CRT (i.e., DEFINE.PDF) packages for FDA submission. • Developed and delivered training for all CRT (i.e., DEFINE.PDF) programming initiatives. • Served as Program Lead for Shire’s first in-house study using my self-built, flexible table macros programs to generate statistical output. Also, developed to check raw data for quality and accuracy. • Developed a Macro Program Library for all validated SAS table and utility programs. • Became an in-house expert in the creation of CRT (i.e., DEFINE.PDF) packages for FDA submission. • Developed and delivered training for all CRT (i.e., DEFINE.PDF) programming initiatives.

    • SAS Programmer II (2004), SAS Programmer III (2005) and Senior SAS Programmer (2006)
      • Jan 2004 - Sep 2007

      • Served as Program Lead for numerous phase II and III NDA submissions. • Participated in several ISS and ISE programming initiatives. • Created derived data sets based on CDISC standards. • Developed, validated, and documented project-specific macros for various studies. • Served as Program Lead for numerous phase II and III NDA submissions. • Participated in several ISS and ISE programming initiatives. • Created derived data sets based on CDISC standards. • Developed, validated, and documented project-specific macros for various studies.

Education

  • University of Mississippi
    Ph.D. - GPA 3.96, Industrial Psychology
  • West Chester University of Pennsylvania
    Continuing Education, Completed Course: Statistical Concepts in the Pharmaceutical Industry
    2004 - 2004
  • Philadelphia University
    Continuing Education, SAS Programming for the Pharmaceutical Industry
    2003 - 2003
  • Bloomsburg University of Pennsylvania
    BA, Psychology
  • Fairleigh Dickinson University
    Master's degree - GPA 3.98, Industrial and Organizational Psychology
    1985 - 1987

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