Edward Hanson Email and Phone Number
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Highly motivated professional with several years of SAS programming in the Pharmaceutical Industry that developed and validated SDTM databases, ADaM databases, Tables, Listings, Figures, and annotated CRFs following both GxP requirements & CDISC compliant dataset creation and formatting. Used Pinnacle 21 to create define.xml & to check the character attributes. Outstanding ability to work with and supervise others and skilled at establishing and complying with protocols and procedures. Worked on Clinical Trials Phases 1 to Phase 4. Made Dean's List at NCSU and ASU.Telephone number: 919-361-1136Email: edhanson1136@earthlink.netSKILLS SUMMARYOperating Systems: Unix, Windows.Computer Languages and Scripts: SAS (eight years experience in the Pharmacology industry using SAS Stat, SAS Base, SAS Macros, SAS ODS, and SAS Graph, fourteen years total experience), Fortran, Pascal, C/C++, HTML/XHTML.Studies Involved in: Oncology (Pancreatic Cancer, Lymphoma, & other cancers, used PROC LIFETEST & PROC MIXED); Infantile Jaundice; Diabetes mellitus; Ophthalmology; Skin Conditions (PSORIASIS, ACNE, Warts); Bipolar I Disorder (Schizophrenia); Systemic Lupus Erythematosus (SLE); Numerous other studies.Apps and Database Management: Microsoft Office, Access.Other skills: Created ACCESS Database for Durham Congregations In Action (DCIA). Experienced with diagnosing, isolating, and resolving complex problems. Experienced with managing client data requests/issues. Experienced with discerning requirements for analysis, hands-on design, and development. Experienced with working with Medicaid data. Experienced with communicating and working with individuals and teams across multiple levels. Worked with the Medicare data. Followed both GxP requirements & CDISC-compliant dataset creation and formattingAcknowledged in the following publications:Genomics 1:349-352; Experimental Neurology 104:223 228; Experimental Neurology 104:186-189; Genomics 6:565-567; Neurology 40:671-676; American Journal of Human Genetics 48:1034-1050; Genomics 9:623-628; The New England Journal of Medicine 324 (20):1381-1429; Nature Genetics 2:37-41; Neurology 43: 1467-1472; American Journal of Human Genetics 57:1317-1376; Archives of Neurology 53:338-344. Wrote the protocols that were used in in Appendix A.3B “Isolation of Genomic DNA from Mammalian Cells” in Current Protocols in Human Genetics, volume 2 (I was not acknowledged in it).
Boy Scouts Of America
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Volunteer LeaderBoy Scouts Of America Jun 2000 - PresentBoy Scouts of America:1. Eagle Scout.2. Vigil Honor.3. Mawat Award for Merit (2012).4. Mawat District Commissioner (2013-2014, 2016).5. Mawat Unit Commissioner (2000 to present).6. Occoneechee Council & Mawat District Camporee Staff.
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Statistical Programmer IiCti Clinical & Trial Consulting Jan 2023 - Feb 20241) As a statistical programmer on the studies assigned, perform the following tasks (80%):a. Assist with SDTM naming conventions for database build specifications.b. Develop SDTM dataset specifications and assist with the development of ADaM dataset specifications following CDISD standards, and developing table, listing and figure (TLF) shells needed to perform the analysis defined in the Statistical Analysis Plan (SAP).c. Review/develop SDTM-annotated CRFs.d. Perform the statistical programming to create SAS dataset deliverables, including SDTM and ADaM datasets, per dataset specifications.e. Review Pinnacle 21 findings and generate Reviewers Guide and Define.xml files.f. Review the SAP and the TLF shells, and provide feedback to the statisticians.g. Perform the statistical programming to create TLFs per mock TLF shells.h. Perform data transfer activities between SAS and various databases and data file formats for internal team members (e.g., Clinical Data Management, Safety) and external clients (e.g., third party vendors, central labs), including file reconciliations.i. Perform statistical programming to review data for protocol adherence, coding consistency and plausibility.2) Collaborate with management to develop and refine departmental SOPs relating to statistical programming (1%)..3) Assist with the training of new statistical programmer employees.4) Carry out all activities according to CTI SOPs and project specific conventions within the framework of Good Clinical Practice/ICH guidelines.5) Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers (3%).6) Maintain accurate records of all work performed and ensure all relevant statistical programming documents are filed in the eTMF per the project-specific eTMF plan (16%).7) Provide input to and participate in departmental meetings.
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Statistical ProgrammerIcon Government And Public Health Solutions Aug 2020 - Oct 2022• Recognize, exemplify and adhere to ICON GPHS's values which centers around our commitment to People, Clients and Performance.• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.• Read, ensure understanding and adhere to all assigned ICON GPHS SOPs and working procedures.• Supports study start-up activities (e.g. reviews, comments on and contributes to study design, protocols, case report forms).• Reviews database specifications and case report forms with oversight.• Supports development of table, listing, and figure shells.• Supports development of department deliverables, such as project reports and outputs, datasets, tables, listings, and figures.• Program and validate CDISC datasets (SDTM, ADaM) and required documentation.• Implements quality control checks throughout programming.• Uploads/downloads data transfers (internal or external).• Assist in the management of documentation required for clinical research and statistical programming.• Supports development of written specifications for derived variables from oral descriptions.• Creates derived variables from written or oral specifications with oversight.• Programs basic statistical procedures in SAS to support planned analyses in clinical research.• Programs specialized statistical procedures (e.g., repeated measures, survival analysis, etc.) and/or SAS/Graph with oversight.• Supports development of complex macros for use by the department.• Supports development of statistical portions of abstracts, presentations, and manuscripts.• Attends department and client meetings as needed.• Supports development of new SOPs and revision of existing SOPs.• Undertakes other reasonably related duties as may be assigned from time to time.• Supports professional activities including presentations at technical conferences (ex. SAS meetings, ISPOR).
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Associate Statistical ProgrammerBiorasi Jun 2018 - Oct 2019Aventura, Florida, UsPrimary Responsibilities:⮚ Program from specifications primarily using SAS® programs for the creation or validation of SDTM domains, ADaM datasets and TLFs (tables, listings and figures) for clinical trials.⮚ Develop and maintain standard programs, macros, templates, and libraries.⮚ Read and comprehend programming specifications for data validation, transformations and analysis programs to create analysis datasets and statistical outputs.⮚ Perform validation of programs and systems used within Data Sciences and Biometrics.⮚ Assist with the documentation of data and outputs for delivery to sponsors. This includes CDISC compliant metadata in the form of annotated CRFs, Define.XML and Data Reviewer’s Guides.⮚ Understand and develop/ validate programs using descriptive statistics.Secondary Responsibilities:⮚ Basic understanding of the role of Data Sciences in clinical trials research.⮚ Understand Define.XMLs using Pinnacle 21.⮚ Assist with the preparation of Data Reviewers Guides for both SDTM and ADaM & review Pinnacle 21 output.⮚ Review project documents (protocol, SAP) as assigned.⮚ Run data analytics programs to assess data quality and consistency across sites in support of clinical monitoring, project management and safety.⮚ Active participant in a programming team.⮚ Communicate as necessary with statisticians and data management personnel.⮚ Assist with the completion of final study reports and other publications as needed.⮚ Understand and follow data science SOPs, guidance, training classes and materials. -
Statistical Programmer IParexel International Sep 2014 - Jun 2017September 2014 – June 2017:Ability to work on several pharmaceutical deliverables in a timely manner and create macros to increase the proficiency of the programs.1. Updated or created SAS validation programs to verify the accuracy of the outputs from production programs.2. Updated SAS production programs to: ⮚ Develop the Study Data Tabulation Model (SDTM) and the Analysis Dataset Models (ADaM) datasets, adhering to the Clinical Data Interchange Standard Consortium (CDISC) guidelines (20% of job). ⮚ Analyze the effectiveness of the study drug by producing Tables and Listings (75%).3. Assisted in the writing of the SDTM Data Transfer Mapping Specifications (2%).4. Annotated the Case Report Forms (CRFs) to explain how the collected data is stored (3%).
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Eclinical Data SpecilalistDocs Global, Inc. Apr 2013 - Aug 2013Actively prepared the GlaxoSmithKline pharmaceutical data for transmitting to the FDA.1) Converted the raw pharmaceutical data into the SDTM dataset needed for FDA approval.2) Created the SDTM annotated Clinical Report Form.3) Verified the accuracy of the transformed SDTM data.
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Computer ProgrammerDataphiles Programming, Llc Oct 2008 - Feb 2012Actively prepared the pharmaceutical data for transmitting to the FDA.1. Wrote SAS production programs to: ⮚ Develop the Study Data Tabulation Model (SDTM) and the Analysis Dataset Models (ADaM) datasets, adhering to the Clinical Data Interchange Standard Consortium (CDISC) guidelines. ⮚ Analyze the effectiveness of the study drug by producing Tables, Listings, and Figures.2. Wrote or updated SAS validation programs to verify the accuracy of the outputs from production programs.
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Computer Programmer ICenter For Demographic Studies At Duke University Aug 2000 - Aug 2006Dynamically involved in assembling and cleaning the National Long-Term Care Survey (NLTCS) dataset. The NLTCS is used to study how people aged 65 years and older survive in today’s society and the challenges they face. 1. Wrote and developed SAS programs to: ⮚ Analyze and merge the NLTCS with the Medicare data to correlate the appearance of particular diseases and disabilities to the elderly. ⮚ Analyze the age of onset for various diseases. ⮚ Import/export study data to/from Excel spreadsheets or HTML files.2. Administered NLTCS dataset and the Center’s web pages.
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Laboratory Research Analyst IDepartment Of Surgery, Duke University Medical Center Aug 1999 - Apr 2000I investigated the action of antibodies on brain cancer. My experience covers: 1) The biodistribution of systemically delivered radio labeled macromolecules. 2) Animal handling skills: a) I.P. and tail vein injections of mice and rats.b) Placement of intracranial cannulas into rats for injection of drug and tumor cells.c) reparation of rat brains for histological studies.3) The study of external beam radiation on the growth fraction on the Human glioma cells. 4) The study of compartmental delivery of antibodies by intrathecal or by direct intratumoral injections.
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Laboratory Research Analyst IDepartment Of Medicine/Division Of Neurology, Duke University Jan 1986 - Aug 1999I was active in human genetic linkage research. My main responsibility in the Tissue Culture/DNA Bank facility was extracting human DNA from blood and the culturing of the human lymphocyte cell lines. During my time there, I became the supervisor for the Tissue Culture/DNA Bank Facility. I created a flow chart for all of the bank’s operations to ensure that all proper procedures and protocols were followed. Moreover, I improved the success rate for establishing a cell line from 60% to 95% by changing how to handle the lymphocyte cell lines from the beginning to cryogenically freezing the cell lines. Furthermore, I coordinated the operations of the facility to work with the primary investigators at Duke. Finally, as supervisor, I developed and wrote many tissue culture protocols. These protocols can be found in Appendix A.3B “Isolation of Genomic DNA from Mammalian Cells” in Current Protocols in Human Genetics, volume 2.During my time at the Tissue Culture/DNA Bank facility, I persuaded a visiting professor from France to save $80,000 by using a $20 Nalgene cryogenic freezing container to freeze cell lines instead of purchasing a step-down freezer. Moreover, I was involved in collected human brain samples from Alzheimer patients through the Rapid Autopsy Program for further Alzheimer’s disease research. In addition, I have some PCR experience in which I screened candidate genes for genetic linkage studies using microsatellite repeat markers, restriction enzyme polymorphisms and SSCP electrophoresis. I optimized PCR reactions by programming the thermal cyclers, and adjusting the pH and magnesium concentration. Then I used the acrylamide, both denaturing and nondenaturing, and agarose gels to separate DNA fragments.
Edward Hanson Skills
Edward Hanson Education Details
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North Carolina State UniversityBiochemistry And Molecular Biology -
Duke UniversityComputer Science
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Appalachian State UniversitySpecial Education And Teaching
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Durham Technical Community College, Durham, NcClinical Trials - Data Management
Frequently Asked Questions about Edward Hanson
What company does Edward Hanson work for?
Edward Hanson works for Boy Scouts Of America
What is Edward Hanson's role at the current company?
Edward Hanson's current role is Statistical Programmer II at CTI Clinical & Trial Consulting.
What is Edward Hanson's email address?
Edward Hanson's email address is ed****@****plc.com
What schools did Edward Hanson attend?
Edward Hanson attended North Carolina State University, Duke University, Appalachian State University, Durham Technical Community College, Durham, Nc.
What are some of Edward Hanson's interests?
Edward Hanson has interest in Photography, Trains.
What skills is Edward Hanson known for?
Edward Hanson has skills like Technology, Computer Program, Laboratory, Polymerase Chain Reaction, Unix, Fortran 95, Html/xhtml, C/c++, Animal Handling, Tissue Culture, Dna Extraction, Php.
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