Biostatistics

Contact

404-***-**** (Mobile)

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

www.linkedin.com/in/claudine-

carnevale-9821059 (LinkedIn)

Top Skills

SAS

Research

Teaching

Languages

French

Certifications

Adult CPR

Pilates Mat Instructor, Levels 1 and 2

Group Fitness Instructor, American

Council on Exercise

Publications

Using Hospital Discharge Files to

Enhance Cancer Surveillance

Diagnostic Chelation Challenge with

DMSA: A Biomarker of Long-Term

Mercury Exposure?

Improving the Health of Infants on

Medicaid by Collocating Special

Supplemental Nutrition Clinics with

Managed Care Provider Sites

Late-Life Depression as a Risk

Factor for Mild Cognitive Impairment

or Alzheimer’s Disease in 30 US

Alzheimer’s Disease Centers

Amniotic Fluid Eicosanoids in

Preterm and Term Births

Claudine Carnevale

Senior Biostatistician

Greater Atlanta Area

Summary

Experienced biostatistician in a wide spectrum of therapeutic areas including rheumatology, central nervous system, neurology, endocrinology, orthopedics, cardiovascular, pulmonology, psychiatry, dermatology, women's health, and immunology. For over 15 years has worked within academic, government, biotechnology and contract research organization environments on research grants and clinical trials.

Specialties: Developing study designs, statistical analysis plans, and clinical study reports including tables, listings, and figures using SAS software.

Experience

Instat Services, Inc.

Senior Biostatistician

May 2017 - September 2018 (1 year 5 months)

Lead Biostatistician for projects assigned, including coordinating all project team activities.

• Monitors project budgets, time spent on the project by the team, and planning appropriate resources.

• Primary contact for the client; supports clients on project related statistical issues.

• Developing scientifically sound study designs and contributing to study design sections of clinical trial

protocols.

• Develops statistical analysis plans (SAP) to meet objectives defined in protocol.

• Provides consultation to clinical project team on any statistical issues related to the trial conduct.

• Leads the analysis of clinical trial data, oversees all statistical programming on the project and addresses all

issues.

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• Programs and/or validates statistical summary tables and reports using SAS for planned and exploratory posthoc

and meta-analyses.

• Performs post-hoc analyses and relevant exploratory analyses of clinical trial data for conference presentation

and manuscript submission.

Chiltern

Senior Biostatistician 2

April 2016 - March 2017 (1 year)

Greater Atlanta Area

Plan, analyze and summarize the results of clinical studies. Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Chiltern and/or sponsor Standard Operating Procedures

(SOPs) or study specific guidelines.

• Apply knowledge of basic and complex statistical design, analysis, and programming techniques • Coordinate statistical activities for multiple projects simultaneously • Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies • Participate in bids & proposal as well as marketing activities for Chiltern • Manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations • Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate • Provide guidance and work direction to less experienced Biostatisticians. Actively monitor project budgets and help staff identify resource or scope of work changes. • Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management

Quintiles

Senior Biostatistician

February 2015 - March 2016 (1 year 2 months)

Plan, analyze and summarize the results of clinical studies. Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Quintiles and/or sponsor Standard Operating Procedures

(SOPs) or study specific guidelines.

• Coordinated the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. • Performed protocol development, sample size Page 2 of 6

calculation, protocol and CRF review. • Advised data management staff on database design, and critical data. May advise on validation checks. • Wrote statistical sections of integrated reports.

Self

Biostatistical Consultant

August 2000 - February 2015 (14 years 7 months)

Provide statistical support including data management, analysis plans, tables, figures, and statistical analysis plans and modeling to researchers as an independent contractor. to physicians, researchers, and biotechnology companies as an independent contractor.

MiMedx Group, Inc.

Senior Biostatistician

May 2014 - October 2014 (6 months)

Marietta, GA

Designed and developed data management tools for monitoring of clinical trials; produced validation reports for end of study/midterm analyses. Developed interim and final reports for clinical trials. Assisted Research and Development Department with statistical analyses for assays and publications.

Provided statistical support for medical directors and liaisons, Used statistical techniques to monitor data quality and ad hoc analyses of clinical studies.

Led the preparation of statistical sections of protocols and analysis plans for various clinical studies and FDA submissions, including sample size estimation, development and definition of hypotheses related to endpoints. Northrop Grumman Contractor for the CDC

Biostatistician

December 2012 - May 2013 (6 months)

Serve as a contract biostatistician for for the Division of Behavioral Surveillance

Public Health Surveillance and Informatics Program Office Page 3 of 6

Office of Surveillance, Epidemiology and Laboratory Services (OSELS) at the Centers for Disease Control and Prevention. Assist in the maintenance and analysis of the Behavioral Risk Factor Surveillance System (BRFSS): http:// www.cdc.gov/brfss/

Provide statistical assistance and consultation regarding areas such as survey and questionnaire design and analysis; sample size determination and selection of statistical methods; the use of appropriate software for data manipulation, editing, weighting, imputation, analysis, interpretation, and reporting.

Serve as an expert using a diverse array of analytic techniques routinely used in the health sciences including sampling; demography; random digit dial dual frame sample design; weighting techniques such as split sample weighting to include data trimming and data raking (iterative proportional fitting); logistic regression; multiple regression; trend analysis; life table analysis; multi-level modeling; and other disease, behavioral, and social science statistical, data analysis, and standardized and customized computer techniques. Emory University

Associate Faculty

June 2007 - March 2012 (4 years 10 months)

Atlanta, GA

Acted as primary or secondary biostatistician in collaborative research with Emory faculty in areas of Alzheimer's disease, women's and children's health, preterm labor, environmental health, geriatrics, clinical trials, HIV/AIDS, and survey analysis.

Prepared data for statistical analysis including acquiring, archiving, converting, cleaning, and managing data sets. Developed statistical design, determined sample size, appropriate sampling techniques, and validation of data for grant proposals and publications. Reported descriptive and inferential statistical analyses, generated reports and graphs, and wrote statistical design and methods sections for grant proposals. Developed associative and predictive models using a variety of statistical techniques, including linear and logistic regression, ANOVA, survival analysis, mixed models, longitudinal data analyses, and structural equation modeling. Used SAS as primary tool for data cleaning, management, and statistical analyses.

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Attended professional meetings, training seminars, SAS users group meetings, and teaching workshops. Served on departmental committees, including curriculum development, admissions, student concerns, and student recruitment. Served on Master of Public Health in Epidemiology degree thesis committee.

Instructed introductory statistic, accompanying SAS laboratory, and SAS programming courses to on-campus students in the Rollins School of Public Health. Instructed distance-based statistical methods courses using SAS for statistical analysis to master's degree candidates in the Career Master of Public Health Program. Developed syllabus and overall course structure, administered grades, and created comprehensive weekly lesson notes and PowerPoint presentations.Co-instructed SAS programming and introductory statistical methods courses for Master of Science in Clinical Research candidates. Coordinated introductory SAS laboratory courses; hired/ supervised fellow instructors and teaching assistants. Virginia Commonwealth University

Senior Programmer/Analyst

August 2000 - October 2004 (4 years 3 months)

Used SAS to prepare data and perform statistical analyses involving cancer surveillance. Used Medicare as well as other claims data sources to supplement information in the Virginia Cancer Registry. Emory University

Associate Faculty

June 1998 - June 2000 (2 years 1 month)

Atlanta, GA

Acted as primary or secondary biostatistician in collaborative research with Emory faculty in areas including effects of mercury exposure, women's and children's health, hypertension and diabetes during pregnancy, vaccine storage and handling, and survey analysis.

Prepared data for statistical analysis including acquiring, archiving, converting, cleaning, and managing data sets. Developed statistical design, determined sample size, appropriate sampling techniques, and validation of data for grant proposals and publications. Reported descriptive and inferential statistical analyses, generated reports and graphs, and wrote statistical design and methods sections for grant proposals. Developed associative and predictive models using a variety of statistical techniques, including linear and logistic Page 5 of 6

regression, ANOVA, survival analysis, mixed models, longitudinal data analyses, and structural equation modeling. Used SAS as primary tool for data cleaning, management, and statistical analyses.

Attended professional meetings, training seminars, SAS users group meetings, and teaching workshops. Served on departmental committees, including curriculum development, admissions, student concerns, and student recruitment. Served on Master of Science in Public Health in Biostatistics degree thesis committee.

Instructed and coordinated introductory SAS laboratory courses for on-campus students in the Rollins School of Public Health. Developed syllabus and overall course structure, administered grades, and created comprehensive weekly lesson notes; hired and supervised fellow instructors and teaching assistants. Education

Medical College of Virginia, Virginia Commonwealth University M.S, Biostatistics · (1995 - 1998)

Virginia Commonwealth University

Coursework, Mathematics; Secondary Education · (1993 - 1995) The College of William and Mary

B.B.A., Finance · (1988 - 1992)

William & Mary

Bachelor of Business Administration - BBA, Finance · (1988 - 1992) Midlothian High School

Advanced Studies Program · (1984 - 1988)

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