Jitha Thomas
Houston,USA
Summary
Biotechnologist with more than 12 years of experience in academic, industrial and project management. Proficient in GMP, GLP, regulatory, and safety requirements. Expert in clinical trial protocols to manage sponsor or investigator-initiated trials for compliance with regard to study specific documents as mandated by sponsors, investigators, patient care providers, or other regulatory agencies.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Clinical SAS Data Analyst/ Biostatistician
IQVIA
New Jersey
02.2017 - Current
- Performed SAS programming in Phase I to Phase IV clinical trials and quality control
- Imported data from different sources in different formats such as Excel, CSV, and database file
- Helped to create efficacy and safety analysis, and datasets for oncology studies
- Generated tables, listings, and graphs using PROC REPORT and PROC GPLOT
- Created macros and used existing macros to develop SAS programs for clinical data analysis
- Reviewed and ensured analysis data and programming code to meet regulatory and company standards
- Worked with applications like R, SPSS and Python to develop neural network algorithms and cluster analysis
- Worked with applications like ggplot2 and shiny in R to understand data and developing packages
- Generated Graphs and Reports using ggplot package in R studio for analytical Models
- R programming skills, including a working knowledge of database.
- Performed advanced analyses such as survival analysis, logistic regression, and multivariate techniques.
- Interpreted website data using advanced analytics tools like Tableau or Power BI.
- Created visualizations of data using various software tools such as Tableau and Power BI.
- Conducted data analysis, created reports and dashboards using Tableau and Power BI.
- Built dashboards using Power BI that provide visibility into key metrics associated with the usage of the EpicCare Ambulatory platform.
- Performed quality assurance on the data wrangling process to ensure completeness and accuracy of results.
- Resolved user inquiries regarding system errors, malfunctions, and data access issues.
Clinical Coordinator
Heavenly Hospice-Houston
Texas, USA
01.2016 - 01.2017
- Provide day-to-day staff, and logistical support to the team, and administrative assistance as needed for the workflow
- Clinical documentation and chart management per requirements, triage patients and schedule appointments
- Assisted in training for clinical trial Managers and Clinical project assistants
- Screen and verify patient communications and phone calls and communicate/interact with patients ensuring HIPAA policies
- Provide clerical, word processing, and staff support meeting coverage, and assist with clinical and financial budgeting
- Directs patient queries to the concerned personnel for quick resolution
- Prepared scripts to ensure proper data access, manipulation and reporting functions with R programming language
- Formulated procedures for integration of R programming plans with data sources and delivery systems
- R programming including some experience with database interfaces.
Clinical Research Coordinator
Clinovex Clinical Research Institute
Kochi, India
04.2014 - 10.2015
- Collection, management and retention of regulatory documents, investigator/institution files, protocol with amendments, CRFs, informed consent forms, financial agreements/disclosures, among other study-related documents
- Creating subject recruitment media, investigator/sub-investigator/research staff, informational and recruitment brochures
- Ascertain appropriate certification, accreditation and other pertinent validations of all research equipment, documents and facilities as required by applicable governing bodies ( IRB, EIC, and GCP)
- Ensuring investigational product accountability
- Conduct site initiation, routine monitoring and close-out visits
- Adhering to standard operating procedures, protocols, and study specific guidelines.
Clinical /Scientific data Editor
Aptara Corp
Technopark, Trivandrum
06.2013 - 01.2014
- Establish accuracy of content, practicality of logic, and appropriate flow of all manuscripts
- Identify and correct spelling, grammar and punctuation errors
- Ensure consistent and precise translation into American and British English
- Maintain technical accuracy of references, footnotes and placement of citations
- Extracted Clinical trial data from Oracle database by using Proc SQL Pass through facility.
Medical Research Editor
Seaview Support Systems
Technopark, Trivandrum
01.2011 - 04.2013
- Worked on clinical data like Demographic data (DM), Lab data (LB), Vital signs (VS), adverse events (AE), and Pharmacokinetic concentrations (PC)
- Annotated CRT's (Case Report Tabulations) and Templates, created edit check specifications and documented them
- Validated the edit check program and the reports for the quality control process and validated the generated reports according to the QC tracking sheet.
Research Associate
Rubber Research Institute of India
Kottayam, India
01.2007 - 12.2010
- Analyzed assay results of biological forms and medication through ELISA, SDS-PAGE, and other testing methods, performed laboratory and manufacturing audits and updated SOPs
- Analyzed and interpreted data using the Biotech ELX808 Plate Reader, the Beckman DU-800 Spectrophotometer, and the GE Molecular Dynamics Densitometer S.I
- Setting up PCR reactions, isolation and purification of DNA and RNA from microbial samples; amplification of specific genes.
Microbiologist/Quality Controller
Strides Arcolab Pharmaceuticals
Bangalore, India
10.2005 - 12.2006
- Set up and management of a new microbiology laboratory, created SOP for laboratory protocols and ordered all necessary equipment
- Conducted various orders with multiple vendors/manufacturers
- Operation of bright field light microscope to analyze and interpret slides
- Microbiology documentation and management of databases
- Media and buffer preparation for quality control.
Education
MS in Biotechnology -
Mahatma Gandhi University
01.2005
Skills
- Operating Systems: Microsoft Windows NT, Mac OS
- Database Platforms: Clin-Trial, MS ACCESS, ORACLE Clinical, MedDRA coding
- Statistical Software: SAS / BASE, SAS / STAT, SAS / SQL, SAS / MACRO, SAS / GRAPH, SAS / CONNECT, SAS / ACCESS
- Software Packages: MS-Office (Word, Excel, Power point)
- Programming Tools: R Programming, Python SAS, SAS Enterprise Guide, SAS Viewer / Universal, SQL, SAS ERROR Log, Open CDISC Validator
- SAS programming
- Data Visualization
- Microsoft Power BI
Certification
- Computer Proficiency: M.S. Office, and Internet Skills Training - Certificate of Completion (Basic and Advanced Levels) - Computer Education Center, India
- Medical Transcription and Terminology- Certification of Training Victoria Institute, Kottayam, India.
- Postgraduate Diploma in Clinical Research and Clinical Data Management- Clinovex Clinical Research Institute, Kochi, India.
- PMP-Certification of Project Management-Project Management Institute, USA
- Certified Base Programmer SAS 9.0.
References
- Dr. Suraj George, surajrcc@gmail.com
- Dr. Vikram G. Pillai, vikgopal@gmail.com
Timeline
Clinical SAS Data Analyst/ Biostatistician
IQVIA
02.2017 - Current
Clinical Coordinator
Heavenly Hospice-Houston
01.2016 - 01.2017
Clinical Research Coordinator
Clinovex Clinical Research Institute
04.2014 - 10.2015
Clinical /Scientific data Editor
Aptara Corp
06.2013 - 01.2014
Medical Research Editor
Seaview Support Systems
01.2011 - 04.2013
Research Associate
Rubber Research Institute of India
01.2007 - 12.2010
Microbiologist/Quality Controller
Strides Arcolab Pharmaceuticals
10.2005 - 12.2006
MS in Biotechnology -
Mahatma Gandhi University
- Computer Proficiency: M.S. Office, and Internet Skills Training - Certificate of Completion (Basic and Advanced Levels) - Computer Education Center, India
- Medical Transcription and Terminology- Certification of Training Victoria Institute, Kottayam, India.
- Postgraduate Diploma in Clinical Research and Clinical Data Management- Clinovex Clinical Research Institute, Kochi, India.
- PMP-Certification of Project Management-Project Management Institute, USA
- Certified Base Programmer SAS 9.0.
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