Clinical Research United States

SUMMARY

HIGHLIGHTS

EDUCATION

EXPERIENCE

JITHA THOMAS

■ Houston, TX 77054 ■ 832-***-**** ■ *******@*****.*** ■ WWW: Bold Profile ■ Biostatistician offering 6-year background analyzing and interpreting data. Sound experience in sampling and validation, developing statistical analysis, managing and manipulating data sets. Proficient in SAS programming, R and Python . Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

• 6 years of SAS programming experience

• Sas Base 9 certified programmer

• Advanced Microsoft Excel and Access skills

• Python Programming

• SQL Database Management

• Statistical software proficiency

• Advanced Statistical Modeling

• Data Quality Assessment

• Neural Networks

• Data Visualization Techniques

• R Programming Language

• Data Integration Techniques

• Data Cleaning

• Statistical Analysis

• Interpersonal Skills

• Research Project Design

• Problem-Solving

• Statistical forecasting

• Advanced data mining

• Data Modeling

• Mathematics and Statistics

• Database Management

• Research Planning

• Big Data Analytics

Ph.D. : Clinical Informatics, Expected in 05/2027

UT Health - Houston, Texas

Associate of Science : Sas Base 9, 04/2017

Statistical Institute - California, United States

Master of Science : Clinical Research And Data Management, 01/2014 ICRA - Bangalore,India

Master of Science : BIOTECHNOLOGY, 02/2005

M.G University - Kottaym,India

SENIOR BIOSTATISTICIAN 02/2017 to Current

IQVIA, NewJersey, United States

As a biostatistician collaborating with clinical team to design and analyses multiple clinical trials and observational studies.

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Provide guidance on study design,sample size determination, and statistical analysis plans.

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Conduct statistical analysis using SAS and R,create reports and presentations of results,and prepare manuscripts for publications.

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Oversee data mangers and analysis in developing statical analysis plans for multiple studies, ensuring accuracy and quality of data analysis.

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Reviewing case report forms,CRF's/SDTM/Adam to ensure that the protocol objectives are met,and the project standards are maintained.

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Working knowledge of medical terminology in clinical trials,clinical trial methodologies,and software systems development.

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Exposure to CDISC Standards,21 CFR Part 11,GXP guidelines. Bioethics,IRB guidelines,HIPPA guidelines and regulatory Submissions(CSR,BLA,NDA,including ISE and ISE0 to support trial-level reporting,and FDA submission.9CSR,BLA,NDA,including ISE and ISS0.

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Designed,planned and executed of biostatics components of research and developmental projects,establishing essential conditions of determining the safety, efficacy and marketability of pharmaceutical and biological products.

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Utilizes sound statistical methodology to conduct studies relating to the product life cycle. In development phase projects,prepares the statistical component of protocols that meet project objectives,health authority guidelines, and clinical methodology standards.

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Explained complex statistical theories,methods, and software.Transforms and interprets data into tabular and graphical formats that are amendable to the principles of statistical interference.

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• Proficiency in R and SAS,enabling effective data analysis and visualization.

• Explained complex statistical concepts to non-statisticians in an understandable manner.

• Performed SAS programming in Phase 1 to Phase IV clinical trials and quality control. Imported data from different sources in different formats such as Excel, CSV and data base file.

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• Helped to create efficacy and safety analysis and datasets for oncology studies.

• Created tables,listings,and graphs using PROC REPORT and PROC G PLOT. Created Macros and used existing macros to develop SAS programs for clinical data analysis.

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Reviewed and ensured analysis data and programming code to meet regulatory and company standards,

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Worked with applications like R,SPSS,and python to develop neural networks algorithms and cluster analysis.

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Worked with applications like ggplot2 and shiny in R to understand data and developing packages.

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• Generated Graphs and Reports using ggplot package in R studio for analytical Models.

• R programming skills,including working knowledge of database.

• Performed analyses of clinical trials for treatment of skin disease and alcoholism.

• Produced tables and listings of safety and efficacy results.

• Produced monthly reports of safety for ongoing trials. Mapped clinical trial datasets to comply with CDISC Study Data Tabulation Model (SDTM) standards. (Produced specifications, transformed data in SAS, produced datasets for internal review and adjusted programs based on comments received, and validated datasets.)

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STATISTICIAN/CLINICAL CORDINATOR 01/2016 to 01/2017 Heavenly Hospice, Houston, United States

Acted as lead programmer producing tables, listings, and analysis datasets for asthma clinical study.

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• Cooperated with other programmers to validate tables and datasets.

• Reviewed dataset specifications for consistency with CDISC SDTM.

• Created macros to do complex manipulations and analysis of PK datasets. Provided day-to day staff,and logistical support to the team,and administrative assistance as needed for the workflow.

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Clinical documentation and chart management per requirements,triage patients and schedule appointments.

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• Assisted in training for clinical trial mangers and clinical project assistants. Screen and verify patient communications and phone calls and communicate /interact with patients ensuring HIPPA policies,

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Collaborate with clinical researchers in the design of clinical trial selection of clinical endpoints, sample size requirements,protocol development, and Research and Case Report Form.

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• Reviewing CRF's,Protocol,SAP of the clinical trail and company SOP. Produce ODS statements to generate different output Formats like HTML,PDF and excel to view them in the web browser.

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CLINICAL RESEARCH COORDINATOR 04/2014 to 10/2015

Clinovex Clinical Research, Kochi

Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.

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Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.

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Assisted in drafting comprehensive research reports summarizing findings, conclusions, and recommendations for further action.

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Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.

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Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.

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Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.

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Managed study budgets and resources to maximize return on investment while maintaining quality standards.

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Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.

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Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.

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Streamlined data collection processes for increased efficiency and accuracy in study results.

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Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.

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Improved recruitment rates by developing and implementing effective patient outreach strategies.

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Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.

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Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.

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Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.

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• Gathered, processed, and shipped lab specimens.

Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

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• Followed informed consent processes and maintained records. Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

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• Maintained compliance with protocols covering patient care and clinical trial operations. Collected data and followed research protocols, operations manuals, and case report form requirements.

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Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.

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Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.

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Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.

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• Monitored patient safety throughout clinical trials and reported any adverse events. Managed patient recruitment, informed consent process and data entry to support trial objectives.

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• Reviewed referral information and kept track of intakes from various referral sources.

• Monitored unit budget to meet financial objectives for spend rate and funding.

• Collected, evaluated, and modeled collected data. MEDICAL RESEARCH EDITOR 06/2010 to 01/2014

Seaview Support Systems, Thiruvananthapuram

Reviewed articles for grammar, spelling, punctuation, syntax, accuracy, and compliance with quality standards.

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Determined readiness of written pieces, made changes, and approved final versions for publication.

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Mentored junior editors and provided constructive feedback on their work, fostering professional growth.

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• Prepared, rewrote, and edited pieces to improve readability and impact.

• Collaborated with graphics department to develop and implement visual elements.

• Adhered to Associated Press and internal style guidelines, educating staff on standards.

• Drove accuracy of content through careful proofreading and fact-checking.

• Developed and maintained editorial standards for content. RESEARCH ASSISTANT 01/2007 to 12/2010

RRII, Kottaym, India

Reviewed vaccine submissions approved 2001 to 2006 and compiled data on pivotal studies and their design.

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• Presented research findings at conferences, contributing to the advancement of the field. Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.

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Streamlined data management processes for increased efficiency and accuracy in research findings.

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Contributed to the publication of research articles in peer-reviewed journals, showcasing expertise in various topics.

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Utilized statistical software for data analysis, generating accurate insights into complex datasets.

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Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.

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• Performed statistical, qualitative, and quantitative analysis.

• Created surveys and questionnaires to collect data for research projects.

• Conducted tests on equipment and instruments for quality.

• Collaborated with other researchers to develop successful research strategies.

• Developed research protocols and procedures to produce accurate results.

• Maintained and calibrated various types of lab equipment.

• Scheduled appointments with test subjects over phone and through email.

• Maintained up-to-date records of research activities and results for future reference.

• Set and oversaw quality assurance guidelines for laboratory work.

• Analyzed results using analytical software and created reports.

• Collaborated with researchers and scientists to design and execute experiments.

• Interpreted laboratory results to provide technical advice to scientists. Operated and performed preventative maintenance on laboratory equipment and instruments.

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• Prepared samples for analysis by performing complex sample preparation tasks.

• Developed new protocols and improved existing laboratory processes.

• Participated in lab meetings and project presentations. ADDITIONAL

TRAINING

• Coordinated and managed laboratory projects and experiments. MICROBIOLOGIST, LABORATORY QUALITY CONTROL 10/2005 to 12/2006 Strides Acrolab Pharmaceuticals, Bangalore

Maintained a safe work environment through proper handling and disposal of hazardous materials according to established guidelines.

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Supported validation activities by performing microbiological testing on new products or processes before full-scale implementation.

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Contributed to the development of new products by providing microbiological insights during product design and testing phases.

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Participated in audits conducted by regulatory agencies, demonstrating strong knowledge of industry best practices and procedural compliance.

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• Programmed computers to store, process and analyze data. Conducted research on various pathogens to develop effective treatments for various diseases.

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• Conducted experiments related to cell culture.

Additional SAS Courses

Conferences:

• SAS Programming 3: Advanced Techniques and Efficiencies

• Macro Language 1: Essentials

• Joint Statistical Meetings (JSM) in 2007 and 2009 Pharmaceutical Industry SAS Group conference (PharmaSUG) in 2008 DIA/FDA CDER/CBER Computational Science Annual Meeting March 22-23 2010

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