Data Analyst Patient Care

Jitha Thomas

**** ********* **, *******, *****-**054

Phone:832-***-****; Email: j ******@*****.***

• 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. Professional Work Experience:

IQVIA, New Jersey, 02 /2017 – Present: Clinical SAS Data Analyst/ Biostatistician.( In house)

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. Heavenly Hospice–Houston, Texas, USA-01/2016 -01/2017: Clinical Coordinator.

• 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. Clinovex Clinical Research Institute –Kochi, India, 04/2014 – 10/2015: Clinical Research Coordinator.

• 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.

Aptara Corp – Technopark, Trivandrum, India, 06/2013 – 01/2014: Clinical /Scientific data Editor.

• 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. Seaview Support Systems - Technopark, Trivandrum, India, 01/2011 – 04/2013: Medical Research Editor.

• 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. Rubber Research Institute of India – Kottayam, India -01/2007 – 12/2010 - Research Associate.

• 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.

Strides Arcolab Pharmaceuticals – Bangalore, India -10/2005 – 12/2006 - Microbiologist/Quality Controller.

• 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. Academic credentials:

MS in Biotechnology-2005

• Mahatma Gandhi University, Kottayam, India.

• Graduated with “First Class” credentials (U.S. GPA:4.0) Certifications:

• 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.

LABORATORY SKILLS:

• Cell Biology: Mammalian Cell Culture, Flow Cytometry, Immunofluorescence, mouse crossing, genotyping, Western blot.

• Molecular Biology: Calcium Quantification, PCR, DNA Isolation, Restriction Enzyme Analysis, ELISA, In vitro cell proliferation assays, apoptosis assays, drug assays, molecular biology techniques, flow cytometry, molecular profiling experiment, Biomarker Technology

• Protein Biology: Protein Purification, SDS-PAGE, Western Blotting.

• Genetics: Site-Directed Mutagenesis, DNA Cloning, DNA Quantification, Primer Design TECHNICAL 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. References:

1.Dr. Suraj George

********@*****.***

2. Dr. Vikram G. Pillai

Vikgopal@ gmail.com

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