Gabe Trout
Cary,NC
Summary
Therapeutic Areas Cardiovascular, Dermatology, Gastroenterology, Infectious Disease, Oncology, Ophthalmology, Psychiatric Disorders Development Phases Phase 1-3, NDA/ISS/ISE submissions Geographic Experience US (FDA)
Overview
28
28
years of professional experience
Work History
Principal SAS Programmer
Veristat
Southborough, MA
03.2018 - Current
- Independently lead the programming activities for various purposes including CSRs, DSMBs, interim analyses, manuscripts, etc
- Mainly support statistical programming of statistical analysis plan (SAP)-planned tables, data listings, and graphs for CSRs, as well as integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data Documentation, programs, programming table of contents, and patient profiles
- In addition, support migration activities in the creation of Standard Data Tabulation Model (SDTM) and production of the Analysis Data Model (ADaM)
- Responsible for monitoring and meeting assigned program milestones and will coordinate and lead a team of programmers to accomplish tasks.
Senior SAS Programmer
Veristat
Southborough, MA
01.2016 - 03.2018
- Expertise in CDISC standards including the migration and conversion of clinical study data to the SDTM and ADaM structure, ensuring compliance to the CDISC implementation guidelines
- Produce SAS programs for QC of CDISC ADaM dataset design and tables/listings development
- Produce and support statistical programming computer systems that are used in the production of statistical analysis plans
- Program and QC planned tables, listings and graphs, help with ad hoc requests and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents and patient profile
- Help data management in standardizing lab normal ranges for local labs
- Develop, enhance, evaluate and validate standardized macros and utility programs
- Assist DM in cleaning data by developing edit check listings
- Generate different styles of plots for stat and medical writing.
Senior Statistical Programming Contractor
Gilhead Sciences through Triangle Biostatistics, LLC
07.2014 - 10.2015
- SDTM production and validation for Phase I projects
- Table, listing, and figure production and validation for Phase I projects
- Production and validation of PK-related datasets, tables, listings and figures
- Generation of CDISC documentation including SDTM specifications, ADaM specifications, and define.xml
- Overview of Essential Functions for Previous Positions.
Principal Statistical Programmer
Inventiv Health Clinical
Cary, NC
01.2013 - 07.2014
- Serve as lead programmer to design and specify the overall approach to a project’s programming tasks
- Produce summary data tables and analysis, as specified in statistical analysis plans
- Development of programming standards
- Development of utility SAS macros
- Coordinate and oversee activities of programming teams.
Senior SAS Programmer/Analyst II
ICON Clinical Research
North Wales, PA
09.2008 - 01.2013
- Provided leadership to both sponsor based and internal projects including coordinating the projects from the start to the completion of all programming as scheduled
- Coordinated programming activities across several trials, manage timelines, provide programming oversight to project programmers, and represent department at client meetings
- Provided technical support and training to project programmers as needed
- Developed and executed statistical analyses under the general guidance of the project statistician
- Designed and developed programs to produce tables, figures, listings and analysis datasets
- Created and maintained programming documents such as analysis dataset specifications, quality control documents and status reports.
Senior Statistical Programmer
Schwarz Biosciences, Inc
Raleigh, NC
10.2007 - 09.2008
- Lead and supported the projects, trials, and staff assigned to own statistical programming operations team and support the global team of Statistical Programmers
- Programmed, validated, maintained, and documented statistical analysis programs for clinical trials on the basis of the Statistical Analysis Plan and of other trial documents (Protocol, CRF, DMM) following standard operating procedures and working documents.
Lead/Senior Statistical Programmer
PharmaNet, Inc
Cary, NC
12.2001 - 10.2007
- Served as the core programming team member to design and specify the overall approach to a project's programming tasks
- Developed SAS analysis datasets to be used in generation of table, listing and graph output
- Created data definition tables to document the source, derivation rules, and function of analysis variables
- Generated and maintained tables, listings and graphs for clinical trials
- Generated clinical study report tables, in-text tables, and ISS/ISE tables for FDA submissions
- Generated independent programs to validate statistical output and provide quality assurance of table, listing, and graph output.
Analysis Programmer
STATPROBE, Inc
Lexington, KY
07.1998 - 12.2001
- Analysis database development
- Table, listing and graph programming
- Database development and maintenance for data used in large Phase IV registry
- Edit check programming
- Program Validation
- Development and maintenance of time tracking system.
Budget Analyst
J. Peterman Company
Lexington, KY
05.1998 - 07.1998
- Development of budget tracking tools using MS Access & Excel software
- Provide assistance in generation of monthly & annual department budgets
- Generate inventory reports
- Generate financial reports as requested.
Project Financial Analyst
ClinTrials, Inc
Lexington, KY
06.1996 - 04.1998
- Generate monthly project status reports detailing project milestones and budget status
- Generate monthly utilization/headcount reports to assist in hiring decisions
- Maintain time tracking system
- Assist in generation of annual department budgets
- Assist with accounts payable and payroll functions
- Generate financial reports as needed
- Develop tracking tools for HR and Records Management departments.
Education
BS - Accounting
University of Kentucky
01.1995
Timeline
Principal SAS Programmer
Veristat
03.2018 - Current
Senior SAS Programmer
Veristat
01.2016 - 03.2018
Senior Statistical Programming Contractor
Gilhead Sciences through Triangle Biostatistics, LLC
07.2014 - 10.2015
Principal Statistical Programmer
Inventiv Health Clinical
01.2013 - 07.2014
Senior SAS Programmer/Analyst II
ICON Clinical Research
09.2008 - 01.2013
Senior Statistical Programmer
Schwarz Biosciences, Inc
10.2007 - 09.2008
Lead/Senior Statistical Programmer
PharmaNet, Inc
12.2001 - 10.2007
Analysis Programmer
STATPROBE, Inc
07.1998 - 12.2001
Budget Analyst
J. Peterman Company
05.1998 - 07.1998
Project Financial Analyst
ClinTrials, Inc
06.1996 - 04.1998
BS - Accounting
University of Kentucky
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