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Greg Ginn is listed as Senior Director, Head of Biostatistics at Realta Life Sciences at ReAlta Life Sciences, based in Winston-Salem, North Carolina, United States. AeroLeads shows a work email signal at abbott.com and a matched LinkedIn profile for Greg Ginn.
Greg Ginn previously worked as Sr. Director, Head of Biostatistics at Realta Life Sciences and Director Biostatistics at Fortrea. Greg Ginn holds Ph.D. Candidate-All But Dissertation, Research And Statistics from The University Of Memphis.
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Greg is a distinguished Clinical Biostatistician with an extensive track record spanning over three decades across prominent sectors, including Medical Device, Pharmaceutical, Biotechnology, and Contract Research Organizations (CROs). His tenure in these industries has been marked by noteworthy achievements, where his expertise has made a substantial impact.In the realm of regulatory submissions, Greg has been a driving force behind the success of Premarket Approvals (PMAs), New Drug Applications (NDAs), Initial Public Offerings (IPOs), and pivotal Business Partnerships. His contributions have played an instrumental role in obtaining regulatory approvals, securing substantial investments, and forging vital industry collaborations.Furthermore, Greg has demonstrated remarkable leadership by overseeing Biostatistics and Clinical Data Management groups, instilling efficiency and precision in these critical functions. His initiatives have transformed several organizations by establishing and cultivating in-house capabilities for biostatistics, SAS programming, data management encompassing Electronic Data Capture (EDC), Interactive Data Capture (IDC), and Dynamic Data Capture (DDC), as well as medical writing.One of Greg's hallmark skills is his exceptional talent in talent management. He excels in recruiting and retaining top-tier staff, fostering an environment where excellence thrives. His ability to attract, develop, and nurture top talents is a testament to his capacity to build high-performing teams that drive results.In summary, Greg's outstanding career showcases not only a wealth of experience but also an unswerving commitment to innovation and excellence. His leadership, expertise, and vision have left an indelible mark on the biomedical and pharmaceutical industries.Specialties: Biostatistics, Clinical Trials, Digital Health
Listed skills include Clinical Trials, Clinical Data Management, Cro, Clinical Development, and 40 others.
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Norfolk, Virginia, Us
Dedicated to Saving Lives by Rebalancing the Inflammatory Response!ReAlta Life Sciences, a clinical stage company focused on rare diseases, has developed a novel class of drugs with unique dual-targeting therapeutic capabilities that rebalance complement and inflammatory processes.
Durham, North Carolina, Us
- Consult on innovative and adaptive clinical trial designs- Provide support for DMC/DSMB data review meetings- Analyze all parts of any clinical study- Provide statistical input into other disciplines' activities and participate in interdepartmental processes- Povide technical solutions and advice to staff and clients on statistical processes- Train less experienced biostatisticians within project activities- Development of Statistical Sections of Protocols and SAPs including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and data display templates
Abbott Park, Illinois, Us
- Provide statistical analysis and statistical reporting clinical trial data- Responsible for the analytical strategy for St Jude CardioMEMS’ device development activities- Manage clinical trial data using Oracle Clinical
St. Paul, Minnesota, Us
- Provide statistical analysis and statistical reporting clinical trial data- Responsible for the analytical strategy for St Jude CardioMEMS’ device development activities- Manage clinical trial data using Oracle Clinical
Atlanta, Ga, Us
- CardioMEMS acquired by St. Jude Medical in June 2014- Oversee all aspects of statistical analysis, statistical reporting and management of clinical trial data- Design, perform and assure quality of analyses of clinical trial dataResponsible for all internal and external biostatistics documents, (SAPs, ISS, ISE, etc.)- Responsible for ensuring patient compliance in the CHAMPION sensor readings database- Responsible for development and maintenance of Biostatistics and Clinical Data Management SOP’s- Responsible for the analytical strategy for all CardioMEMS’ device development activities- Recruit, retain and develop qualified staff to execute biostatistics and data management strategy
• Supervise and oversee the managers and employees of the statistical, programming and data management departments.• Develop, implement, review, and modify company standard operation procedures (SOPs).• Assist in the development of company departmental training curriculums and conduct, arrange and oversee training seminars.• Serve as lead statistician on assigned projects and serve as statistical resource for company personnel.• Design or review Case Report Forms (CRFs) as required• Communicate with clients as needed to ensure project quality and continuity.• Represent client at FDA and panel meetings as requested.• Identify, oversee, develop and implement programming strategies to improve efficiencies.• Identify, research, evaluate and help to implement new data management systems.• Assist in preparing estimates, work orders and proposals for new and existing clients.• Represent the company at local and national industry meetings and conferences.
Atlanta, Ga, Us
- Oversee all aspects of statistical analysis, statistical reporting and management of clinical trial data- Design, perform and assure quality of analyses of clinical trial dataResponsible for all internal and external biostatistics documents, (SAPs, ISS, ISE, etc.)- Responsible for ensuring patient compliance in the CHAMPION sensor readings database- Responsible for development and maintenance of Biostatistics and Clinical Data Management SOP’s- Responsible for the analytical strategy for all CardioMEMS’ device development activities- Recruit, retain and develop qualified staff to execute biostatistics and data management strategy - Contributing member of Clinical Operations department
- Oversee all aspects of analysis, statistical reporting and medical writing of clinical trial data- Developed company’s first biostatistics, data management and medical writing group in RTP office- Design, perform and assure quality of analyses of clinical trial data- Coordinate efforts of managers and/or statisticians and statistical programmers- Have overall responsibility for SAS programming and quality control of SAS programs- Managed team that validated and implemented in-house clinical data management system Initiator® Clinical Trial Management System- Coordinate day to day operation of projects within Biostatistics and Data Management- Manage the statistical aspects of the project to completion and providing the biostatistical project team with the information and guidance to complete the project- Conduct and participate in client presentations
Winston-Salem, Nc, Us
- Responsible for all biostatistics and clinical informatics strategy, execution and reporting- Responsible for all internal and external biostatistics documents, (SAPs, ISS, ISE, etc.)- Participated as member of Targacept project teams supporting clinical and pre-clinical development- Responsible for development of Biostatistics and Data Management SOP’s- Responsible for the analytical strategy for all Targacept compounds and development activities- Recruited, retained and developed qualified staff to execute biostatistics and data management strategy – currently managed Senior SAS programmers, one Senior clinical data manager and external medical writers- Contributing member of Clinical Development and Regulatory Affairs Management team- Selected and implemented the first in-house computer system for clinical informatics and statistical analysis using Electronic Data Capture and SAS software.
- Provided biostatistics, SAS programming and data management consulting services to pharmaceutical, medical device, contract research organization and research laboratories
Us
- Selected and implemented first in-house computer system for clinical data informatics and statistical analysis using Clintrial and SAS Data Warehouse/iBiomatics products- Responsible for management of all biostatistics strategy, execution and reportingcompounds- Recruited, retained and developed qualified staff to execute biostatistics and data management strategy –managed three programmers and two clinical data transcriptionists
Jackson, Tn, Us
Taught classes in introductory statistics for nursing students Created statistics labs to enhance learning through hands-on, health-related applications
Minneapolis, Mn, Us
- Responsible for the clinical informatics and biostatistics for all clinical studies- Managed all aspects of multicenter IDE studies for spinal orthopedic devices - includes site monitoring, data verification, and training of study personnel - Communicated with FDA and at Panel Meetings- Produced reports and assisted with 510(k) and PMA submissions- Had responsibility for obtaining IDE approvalsConducted investigator/study coordinator training and performed study site monitoring- Responsible for database design and statistical analysis- Recommended and performed Bayesian analysis to shorten time to PMA (referenced in FDA’s Draft Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials, May 23, 2006)- Submitted PMA resulting in successful approval of Medtronic Sofamor Danek’s first PMA: INTER FIX Threaded Interbody Fusion Device
- Taught class in introductory statistics for nursing students- Instructed students in basic SPSS for Windows usage- Utilized health-related applications exclusively
Rahway, New Jersey, Us
- Provided/directed biostatistics and clinical infomatics for entire HealthCare Products Division- Responsible for statistical design of clinical studies for prescription-to-OTC switches, NDA submissions, claims support, and product safety, efficacy, and development- Assisted Medical Staff and R & D in protocol development and study design - Provided statistical analyses and report for clinical studies- Assisted with statistical analysis and hardware and software support for R & D- Worked in the following therapeutic areas: dermatology, upper-respiratory, mycology, analgesia, anti-infectives, and podiatric treatment and devices
Provided statistical analysis of epidemiologic and health services research data Assisted in the design and analysis of health science research projects Collaborated with investigators on research projects for publication and presentation Managed research data and supervised data-entry personnel Provided hardware and software support for Center for Health Promotion
Taught Consumer and Career Mathematics and Pre-algebra in 7th grade and 9-12th grade classes Provided computer literacy lessons using a personal computer
Quick answers generated from the profile data available on this page.
Greg Ginn works for ReAlta Life Sciences.
Greg Ginn is listed as Senior Director, Head of Biostatistics at Realta Life Sciences at ReAlta Life Sciences.
AeroLeads has found 1 work email signal at @abbott.com for Greg Ginn at ReAlta Life Sciences.
Greg Ginn is based in Winston-Salem, North Carolina, United States while working with ReAlta Life Sciences.
Greg Ginn has worked for Realta Life Sciences, Fortrea, Abbott, St. Jude Medical, and Cardiomems, Inc..
You can use AeroLeads to view verified contact signals for Greg Ginn at ReAlta Life Sciences, including work email, phone, and LinkedIn data when available.
Greg Ginn holds Ph.D. Candidate-All But Dissertation, Research And Statistics from The University Of Memphis.
Greg Ginn is listed with skills including Clinical Trials, Clinical Data Management, Cro, Clinical Development, Fda, Biostatistics, Edc, and Medical Devices.
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