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0-5 years of experience
Initiated, monitored, and closed domestic clinical studies for both approved and investigational devices. Responsible for auditing 10 study sites across the United States, including management of data collection and adverse event reporting. 25% of position involved travel and meeting with clinical investigators and site personnel.
- Designed and composed clinical protocol, case report forms, and statistical plan for investigational device exemption (IDE) trial.
- Direct communications and panel presentations to the FDA regarding study parameters and protocol development for IDE
- Assisted with protocol development for post-market studies, study site selections and contract negotiations.
- Created and managed clinical databases. Generated statistical reports for FDA submissions, publications, and internal uses.
- Thoroughly familiar with GCPs and FDA regulations in designing and executing the company’s clinical research projects.
0-5 years of experience
Earned promotion to Biostatistician III level and presented with Best Analyst Award in 2011.
- Created reusable Macros and developed SAS Programs for Data Cleaning, Validation and Analysis and Report generation.
- Performed Quality Checks on the existing table, listing and figures.
- Analyzed and examined complex data and evaluated the statistical methods and procedures used to obtain data in order to ensure validity, applicability, efficiency, and accuracy.
- Attended project team meetings, worked with Data Managers and Clinical Research Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.
- Reported results of the statistical analyses in the form of graphs, charts, and tables using superb documentation practices to ensure data integrity and traceability.
- Designed impeccable and user-friendly worksheets, table formats, and charts and supervised their presentation.
0-5 years of experience
Independently performed statistical analysis for 5 research projects.
- Collaborated with another statistician in performing statistical analysis for 2 research projects.
- Worked extensively with large datasets with sample sizes over 50 and with over 20 attributes.
- Prepared analysis results in Excel and presented statistical results of the research datasets to surgeons and research interns.
- Applied advanced statistical techniques for existing and on-going research projects.
- Guided research interns in writing their research presentations and manuscripts for peer-reviewed journals.
6-10 years of experience
Held full responsibility for activities involving data management, statistics and programming for several large phase III clinical trials
- Conducted edit checks, communicated with site investigators to resolve any data issues
- Created analysis datasets and decided analysis methods based on data structures and analysis objectives
- Conducted statistical analyses, generated tables and figures, wrote method and result sections for publications
- Responded to the reviewers’ comments for statistics session
- Validated statistical analysis results for the whole group
0-5 years of experience
Developed the statistical analysis plan (SAP) for a wide range of clinical trials of cancer.
- Conducted statistical power analyses and sample size calculation using SAS.
- Cleaned and analyzed clinical data in SAS with various procedures and macros.
- Performed the statistical analyses including survival analysis, linear regression analysis, longitudinal analysis and logistic regression analysis, and statistical modeling (GLM, Logistic model, Cox model, GEE and Mixed Model) of clinical trials and observational studies using SAS and R.
- Participated in preparing the statistical sections in peer-reviewed medical manuscripts.
- Presented and interpreted methods and results to principal investigators on a regular basis.
0-5 years of experience
In consultation with investigators, medical personnel and other statisticians, responsible for administering Alzheimer’s Disease clinical trials
- Assisted in the design of drug trials
- Performed primary efficacy analyses and all secondary analyses for FDA-approved drug trials
- Helped design databases and maintained data integrity during extraction, manipulation, processing, analysis and storage
- In consultation with various safety and monitoring committees, performed interim safety and efficacy analyses while maintaining double-blind aspect of trials
- Designed, performed analyses, wrote and edited materials for protocols and manuscripts
0-5 years of experience
Supervisory position for major clinical trial CRO drug analysis contract with a Top-5 Pharmaceutical Company
- Managing a team of 6 biostatisticians, 4 statistical programmers, and 1 database analyst
- Wrote complex SAS programs and macros, and solved problems with SAS programs and analysis methods
- Reviewed analyses and statistical programs produced by biostatisticians and programmers
- Planned for and represented the [company name] team in over 30 meetings with the pharmaceutical company
- Produced 5 completed statistical analysis plans in collaboration with the team (additional SAPs in production)
- Preparing and co-authoring at least 7 planned abstracts and research papers for publication
- Served as the primary contact between Columbia, the trial CRO, and the pharmaceutical company
0-5 years of experience
Provided statistical expertise for the design, execution, and analysis of pharmacy claims data in support of the Healthcare Econometrics department.
- Partnered with the Pharmacy Benefit Administration and Clinical Healthcare Management departments to identify, measure and model factors affecting costs and quality.
- Assisted in developing reports following the CMS Medicare Part D reporting requirements
- Managed monthly/quarterly integrated progress reports for senior management.
- Assigned as Econometrics representative for the National Provider Identifier (NPI) workgroup, identifying changes needed to statistical databases to conform to new CMS regulations.
0-5 years of experience
Planned, conducted, and evaluated clinical trials to assess communicable disease diagnoses (e.g. hepatitis) sensitivity and specificity
- Provided epidemiological expertise in research methodology and design, study protocol development, case report form design, database structure, and analysis plan for diagnostic trials
- Developed and managed data collection systems, determined appropriate statistical methods and performed the statistical analysis on data from various epidemiologic studies
- Generated, organized, and displayed complex statistical analysis using SAS programming
- Reviewed and monitored diagnostic clinical trial sample population information, including demographics and the results of laboratory tests, to identify epidemiologic trends
- Collaborated with clinical affairs and other internal groups to complete FDA submissions, including reviewing the reports to ensure accuracy and clarity
- Assisted in responding to FDA inquires (e.g., conducting statistical analysis, producing meta analysis and reviewing official response letters for completeness and accuracy)
- Audited in-house and clinical site data
0-5 years of experience
Developed SAS programs to analyze economic, clinical, outcomes, and quality of life data from multi-center clinical trials on cardiovascular devices.
- Calculated cost components for clinical procedures and for hospitalizations.
- Computed measures for resources, clinical events, outcomes, quality of life (e.g., SF-36), and cost/effectiveness ratios.
- Performed statistical analysis on quality of life data.
- Conducted data checking and review.
- Ran bootstrap simulations and sensitivity analysis to evaluate effects of parameters.
0-5 years of experience
Developed procedures to align with industry best-practices (ICH, FDA) for study design, sample size estimation, data management, statistical analysis, and SAS programming.
- Managed and developed junior-level statisticians and SAS programmers.
- Manage Contract Research Organizations for data management and statistical request overflow.
- Interacted (paper) with FDA (CDER) in regards to NDA clinical trial requirements.
- Provided statistical services for Phase I-IV clinical trials/studies, product reliability/stability testing, and Integrated Summaries of Safety.
0-5 years of experience
Trial statistician on several Oncology Phase I trials involving treatments of chronic myelogenous leukemia and solid tumors. Responsibilities included protocol development, definition of statistical methods and analyses, collaboration with team members.
- Assisted in the writing of Investigator’s Brochure and responses to queries from regulatory authorities.
- Involved in the development of statistical methodology in the detection of possible nonadditive responses observed in the combination of agents.
- Analyzed data from biomarker experiments including mutations and the relationship of genetic markers to clinical outcomes.
- Assisted in manuscript preparation. Initiated abstract for submission for ASCO meeting.
- Worked with clinical staff to provide exploratory analyses including graphical displays to assist in the interpretation of trends in clinical outcomes.
0-5 years of experience
Project title: Developmental and Gender Differences in Physiological and Cognitive Responses to Soda Additives
- Coordinated with the investigators to understand the specific analysis task and to help them with the interpretation of the analysis results.
- Performed data cleaning and pre-analysis coding for the longitudinal data.
- Developed SAS programs to import external data into analysis SAS data and to generate data sets, tables, graphs and descriptive statistic.
- Performed analysis of repeated measurements 3*2 crossover design by employing the PROC MIXED procedure in SAS and delivered the analysis results in different formats and destinations using ODS.
- Developed SAS macros to facilitate the data assembly and analysis process.
6-10 years of experience
Center for Biostatistics in AIDS Research
- Performed statistical work in AIDS clinical trials: – Participated in study protocol and form development.
- Wrote and implemented Statistical analysis plans (SAPs).
- Monitored subject accrual, randomization, data collection and cleaned data to ensure study quality.
- Performed statistical analysis.
- Wrote statistical reports and helped writing manuscripts.
- Served in key functional committees including randomization and forms committees to ensure the correct
0-5 years of experience
Developed clinical trial designs for all company-developed medical devices including
cervical cancer screening, noninvasive glucose monitoring, and diabetes screening
- Developed and successfully defended pre-IDE clinical trial design to the FDA
- Advises executive team on risks associated with selecting criteria used for determining
- Managed a self-initiated $250K company-wide reliability engineering program
- Provided critical and strategic consultation to senior executives of company sponsor
- Received maximum salary increases and stock option awards every year employed
0-5 years of experience
Contracted to the Air Force C-STARS program (a best practices training exchange between Air Force medical personnel and Maryland’s premier trauma center, Shock-Trauma Center).
- Performed ANOVAs, t-te[company name], and logistic regression in SAS.
- Discussed grant proposals and helped refine and target them to the Air Force needs.
- Calculated sample sizes for grant proposals.
- Wrote statistical analysis plans.
- Collaborated on a $1m project for rapid prediction of blood transfusion. This was an observational clinical study.
- Certified in human subjects protection and animal protection for IRBs and IACUCs.
- Co-author on paper, see addendum.
0-5 years of experience
Analyzed epidemiological/health data and perform statistical modeling
- Designed survey forms for data collection using SPSS for cancer research investigators
- Performed database management and supervise study databases
- Involved in writing statistical results section of publications and presentations
- Provided assistance in statistical analysis to medical professionals
0-5 years of experience
- Expedited microarray analysis implementing PCA/multivariate analysis/limma/Empirical Bayes Statistics to measure gene expression and determine gene function
- Analyzed pathway and system biology data using linear mixed models, ANOVA and post hoc, nonlinear regression and dose response model
- Developed survival analysis and propensity score matching on observational study about effect of recombinant factor 7 on alveolar hemorrhage
- Developed meta-analysis of expression profiling studies on human peripheral blood mononuclear cells from patients with pulmonary arterial hypertension
- Merged large data from UHC Clinical Database/Resource Manager to identify patients with smoke inhalation-associated acute lung injury (SI-ALI) using SAS SQL and risk factors associated with SI-ALI implementing logistic regression and sensitive analysis
- Processed epidemiology data of influenza using trend analysis, time series and logistic regression
- Evaluated and interpreted collected data, reported findings and consulted with non-statistical investigators
0-5 years of experience
Provided statistical guidance for 4 ongoing clinical oncology studies which were contracted to CRO and checked annual safety update report
- Validated statistical analysis and sample size (Simon’s two-stage design) for ongoing phase II studies in oncology
- Joined conference/teleconference study team meetings with inside or outside colleagues once every week for each clinical study in oncology
- Revised SAP, charter, and SAP for independent DMC (Data Monitoring Committee) for contracted clinical studies in oncology
- Participated in DMC meeting with independent DMC members and colleagues
0-5 years of experience
Interacted directly with clients (Doctors and/or other Hopkins’ researchers) to determine project goals and develop an appropriate analysis plan
- Analyzed clients’ research data and developed concise reports
- Presented results to clients in face-to-face meetings
- Taught statistics and statistical programming to clients and students during weekly
0-5 years of experience
Managed database from multi-year and multi-location trials and surveys.
- Analyzed continuous data using ANOVA/MANOVA, GLM, mixed models, and nested models.
- Evaluated responses and performances using robustness and stability analysis.
- Plotted and graphed scientific findings.
- Authored or co-authored 7 journal articles and 1 conference abstract.
0-5 years of experience
- Responsible for performing statistical analysis and survival analysis of breast cancer data using multivariate prognostic statistical models coded in SAS.
- Performed statistical and quantitative health risk analyses on medical topics utilizing computerized analytic tools to develop risk assessments.
- Applied statistical research techniques for critical evaluation of epidemiological literature.
- Designed and managed research databases to perform statistical analyses utilizing computer-based statistical methods, (Sigmaplot, PC SAS, and Egret).
0-5 years of experience
Developed and maintained databases using Microsoft Access.
- Developed SAS programs for data cleaning and validation.
- Extracted data using SAS/ACCESS, SAS/SQL procedure and created SAS data sets.
- Designed analytic data set specifications, manipulated, merged and restructured analytical data sets from large-scale data in SAS.
- Created complex and reusable MACROs and extensively used existing MACROs.
- Produced output in different format (.rtf, .html) using SAS ODS output.
- Generated scientific tables, listings and graphs using SAS for journal papers and presentations.
- Conducted data analysis on obesity, diabetes, cardiovascular disease study using statistical techniques such as regression models, analysis of variance, covariance, survival analysis, survey data analysis, mixed model, generalized estimating equation approach (GEE), categorical and longitudinal data analysis, etc.
0-5 years of experience
Lead statistician in Medical Affairs Group. Make timeline projections, resource estimation for all MAF studies. Managed 2 vendors.
- Provide statistical oversight for all 5 compounds: Aldurazyme, Firdapse, Naglazyme, Kuvan, and Vimizim. Supported various post-market regulatory commitments, and publications.
- Lead statistician for seven studies including three large registry studies, three Phase IIIB studies, and one repeated cross-sectional surveillance study.
- Authorship of 2 manuscripts which were published in Journal of Inherited Metabolic Disease, and American Journal of Medical Genetics respectively. Work as the lead statistician on both manuscripts.
- Planned for several global registry trial. Provide recommendations to protocol design, write statistical section of the protocol, prepare SAP.
- Interpreted results to internal and external audience, including medical directors, publication strategy group, publication advisory board members, and commercial department.
- Work with regulatory affairs, medical director, clinical operational, statistical programmers for PMC/PMR request.
- Work with Pharmacovigilance, Biometrics, Medical director, clinical operational, statistical programmers for DMC.
0-5 years of experience
Compared methods of selecting Single Nucleotides Polymorphisms via performing a case-control association study.
- Applied Proportional Hazard Model in SAS on Cystic Fibrosis dataset, determining the impact of gender, genetic categories, and exercise status on the survival of patients.
- Maintained and improved Diabetes project website.
- Installed an authorization and authentication mechanism for the access to the website.
- Investigated the association between genetic markers and susceptible disease alleles in Systemic Inflammatory Response Syndrome.
- Compared biostatistical methods of estimating genetic and non-genetic factors, and their confidence intervals, in a case-control simulated data sample.
0-5 years of experience
Performed statistical analyses with software STATA. Analyses included stepwise logistic regression, simple and multivariate statistical analyses.
- Designed and analyzed clinical trials. Managed the collection, cleaning and storage of clinical data.
- SAS – 15 years experience. In depth knowledge of SAS programming language, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/ETS, SAS Macro Language, JMP, Enterprise Guide, and Enterprise Miner.
- Familiar with R
- Windows, Microsoft Excel, Powerpoint, Access – excellent knowledge.
- SQL – excellent knowledge.
- Familiar with Tableau
- Demonstrated ability to quickly learn new technical skills
0-5 years of experience
Perform assigned statistical analyses and technical tasks on epidemiological and health-related studies
- Manage assigned task with the responsibility of remaining on or under budget and deadline constraints
- Extract data from existing databases or literature and performs statistical reviews
- Write various reports or section of reports
- Prepare tables and graphics using statistical software packages such as SAS and STATA
- Statistical Analysis of Public Health Data – Analyzed and investigated data from the Environmental Protection Agency on the nature and extent of chemical contamination in the sediment of local rivers, lakes and reservoirs. All findings were presented graphically and in a written report within time and budget constraints.
- Data Management of Public Health Data – Cleaned and managed data from the Human Smoking Behavior Study for the Center of Disease Control and Prevention. Other responsibilities included generating statistical summaries, new variables, and an accompanying codebook for delivery to the CDC for further analyses.
- Graphical Presentation of Public Health Data – Performed exploratory data analyses and created tables/graphs on data from the National Children’s Study as a part of methodological planning and development support for the program.
0-5 years of experience
Provided statistical support for developing approach, performing analysis, Design of Experiments, determination of sample size, number of runs, and setting acceptance criteria for Provenge vaccine Process Validation and manufacturing.
- Evaluated statistically molecular, cellular, and protein data for IND/NDA submission to the FDA (with a successful approval) and Provided Quality Engineering support for developing cleaning validation approach for Commercial Immunotherapy Manufacturing Facilities.
- Developed Risk Analysis and FMEA database, system, documentation and full evaluation of manufacturing processes. Supported Biostatistics department.
- Provided general statistical training.
0-5 years of experience
Clinical Researcher/Coordinator
- Project coordination and management of clinical research conducted in the Department of Medicine, including investigator initiated studies, industry clinical trials, and federal/nonprofit grant-funded studies
- Provide advanced biostatistical and analytical consulting and support in study design and publications
- Promoted to “Biostatistician/Research Project Specialist” from “Clinical Researcher/Coordinator” in July 2014
0-5 years of experience
Developed and managed databases for multiple clinical trials
- Wrote the Manual of Operations and Procedures for two multicenter clinical trials
- Provided guidance to research fellows and investigators about research proposals, analysis methodology and trial design
- Performed statistical analyses and assisted with manuscript preparation
0-5 years of experience
- Did statistical analysis on clinic trial studies (GSK REDUCE trial on prostate cancer).
- Used statistical software (SAS, R, PLINK) to do analyses on Genome-Wide Association Study (large genetic dataset, more than 7 million observations) on several diseases such as Prostate Cancer, Liver Cancer, Azoospermia.
- Designed tables and statistical procedures for specific research studies.
- Wrote statistical computer programs and reviewed computer output for consistency and quality.
- Used variety of tools such as SAS, R, Excel, and SQL and C #/C++ to organize various types of dataset, created and managed the database of different projects.
- Prepared and reviewed reports, contributed to the statistical methods section and verify for completeness and consistency for reports.
- Collaborated with biomedical investigators and assist in developing objectives, designed sampling, randomization and data collection procedures to achieve study objectives.
- Collaborated with clinic and other personnel, included analyst/ programmers in monitoring and assessing data quality.
0-5 years of experience
- Worked as a statistical consultant with physicians and pharmaceutical research associates to examine global longitudinal end-stage renal disease outcome data by identifying issues, formulating hypothesis and analyses plans.
- Provided development of statistical models, analyses, interpretation and presentation of results for non-statistical audiences.
- Created SAS code to model multivariate linear and logistic regressions, and survival analysis models in PC and batch processing mode.
- Published peer-reviewed evidence-based medical research papers and presentations.
- Worked in collaboration with pharmaceutical company to evaluate drug efficacy.
- Interpreted, disseminated, and presented medical research findings at national and international scientific meetings.
0-5 years of experience
- Worked with clinical research team members to provide statistical input for clinical trial protocol development; including study design, randomization, sample size justification, power calculations, study endpoints selection, CRF and questionnaires development, and edit check
- Performed statistical analysis for clinical trials and market survey studies: statistical analysis plan development, statistical model selection (general linear model, mixed model, logistic regression, ANOVA, survival analysis, etc), manipulated large datasets, generated and validated tables, listings, and graphs using SAS, reviewed study reports
- Supported regulatory submissions to FDA; assisted with FDA questions, responses, meetings
- Statistician for STAR 3 Trial (Sensor-Augmented Pump Therapy for A1C Reduction): supported project-related clinical and marketing activities, including annual safety report, manuscripts, posters, and joint author several manuscripts, presentations, and posters
- Interpreted statistical results to non-statisticians
- Reviewed and QC-ed statistical work provided by outside vendors (CROs)
- Developed and revised Statistical Analysis Plan Template, SOPs for Clinical Research Department
0-5 years of experience
Planned and programmed analysis dataset (derived datasets)
- Perform statistical analysis
- Performed independent SAS programming for validation of tables and listings
- Prepare and reviewed statistical analysis plans based on the protocol
- Developed mock displays for statistical tables and listings
- Performed sample size and power calculations and validations using PASS
- Reviewed and provided feedback on study protocols and other study related documents
0-5 years of experience
Analyzed pilot study trial data to establish if drug treatment was effective in reducing hot flashes
- Determined an association between sleep trouble and sleep severity during menopausal time periods
- Compiled preliminary data for basis of future pilot studies
- Utilized SAS to create graphics and program code for statistical analysis
- Performed analysis using logistic regression, generalized estimating equations, SQL, ANOVA, chi-squared tests, etc.
0-5 years of experience
Analyzed pilot study trial data to establish if drug treatment was effective in reducing hot flashes
- Determined an association between sleep trouble and sleep severity during menopausal time periods
- Compiled preliminary data for basis of future pilot studies
- Utilized SAS to create graphics and program code for statistical analysis
- Performed analysis using logistic regression, generalized estimating equations, SQL, ANOVA, chi-squared tests, etc.
10+ years of experience
Worked with investigators to design, construct and maintain databases to more effectively evaluate patient information.
- Utilized patient information to create reports, which helped health providers to make more informed patient decisions.
- Analyzed data from medical records to stratify levels by health center to compare best practices by facility.
- Analyzed demographics to create preventative care programs
- Created SAS report information to provide leadership to make better decisions and introduce cost effective solutions
0-5 years of experience
- Combined, merged, and modified data sets from children’s IMT data and DNA methylation data from the Children’s Health Study.
- Performed statistical analyses using SAS Macro.
- Exported data from SAS to Excel to observe potential confounders and interaction variables.
- Produced tables summarizing results onto data spreadsheets to present comprehensive summaries of the findings to professional peers.
0-5 years of experience
- Performed statistical consulting for researchers at VARI and MSU College of Human Medicine
- Handled basic statistical inquiries; investigated and implemented advanced methodologies
- Conducted power analyses via exact methods or simulations
- Developed intuitive data visualizations to communicate experimental outcomes
- Applied statistical learning algorithms to extract knowledge from high dimensional data sets
- Researched, implemented and compared pipelines for the analysis of NGS data
- Deployed and administered GitLab backed git version control system to improve project tracking and project reproducibility
0-5 years of experience
Recreated bedtools, a fast, flexible, linux command line toolset for genomic arithmetic, written in C++. New version is up to 60x faster than previous ones. Used templating and polymorphism to handle ten bioinformatics file format types, four compression types, and four file/stdin input types. Bedtools is also now faster than bedops, a competitor whose sole marketing claim had been superior speed.
- Refactored code base for modularity, allowing vastly easier maintenance and rapid future development
- Created automated regression testing tool that enables bedtools to compare correctness, speed, and memory footprint against prior versions of itself for many combinations of simulated dataset size and density
- Added many new unit tests to ensure correctness of all prior features when adding new ones
- Provided support for bugs and enhancements on open source github site
0-5 years of experience
Provided methodological and statistical consultation and support for clinician and student researchers.
- Principal Biostatistician for randomized clinical trials, longitudinal studies and registries.
- Participated in daily operational activities such as research seminars, and committees for research development within the clinical research facility.
- Statistical analysis of clinical trial data and longitudinal studies.
- Managed research assistants, database managers, database developers, bioinformaticians, and analysts
- Developing SOPs for clinical research institutions and for specific projects, fully incorporating QA/QC
- Proposal development, writing and submission
- Promoted scientific visibility by leading development of scientific presentations and publications.
0-5 years of experience
- Performed meta-analysis of gene signatures in breast and lung cancers
- Participated in data collection and database generation for the future meta-analysis
- Created inclusion/exclusion criteria which are used to decide whether an article is qualified for inclusion according to the objectives of the study project
0-5 years of experience
- Created or reviewed statistical analysis plans.
- Reviewing the statistical sections of protocols and clinical study reports.
- Reviewed programmed tables, figures, and listings.
- Set up and conducted meetings.
- Provided support for all clinical studies as required.
- Provided training for the preparation of statistical analysis plans; Microsoft Word; and Adobe Acrobat.
0-5 years of experience
Managed data in Excel, Access and SAS for human subject trials
- Aided in the development of manuscripts, grant proposals, presentations, and study reports
- Created SAS code for data analysis and data management
- Wrote statistical results
- Worked with project manager in getting a new study off the ground in regard to timing, recruitment techniques, creation of databases, and training of necessary personnel
0-5 years of experience
- Performed statistical analysis of pharmacokinetic and dermatological data from clinical
- Used FDA required statistical methods and compiled statistical reports to assess drug
- SAS programming, data manipulation and cleaning, SAS program validation
- Estimated pharmacokinetic parameters involved in drug metabolism
- Study protocol development and study planning initiatives, preparation of statistical
0-5 years of experience
- Staff Associate in Psychiatry
- Managed large computerized databases for 9 year study of anxiety disorders
- Organized and standardized data collection
- Designed databases and questionnaires
- Performed univariate and multivariate statistical analyses
- Supervised 5 research assistants
- Implemented and organized Manufacturers Hanover Corporate Challenge Road Race Team
0-5 years of experience
Perform Basic Statistical Functions on 1,500 case data set for 2 Malaria publications using SAS
- Analyze and generate basic reports using Microsoft Word
- Train 2 research interns on data analysis and management
- Merge, Organize, Sort and Exclude Cases Using Microsoft Excel and SAS
- Recode Immunogenic, Genetic and Gender Variables
6-10 years of experience
Provided/directed biostatistics and clinical informatics for entire HealthCare Products Division
- Responsibility for statistical design of clinical studies for prescription-to-OTC switches, NDA
- 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
0-5 years of experience
- Managed 2 statistical projects to support a group of epidemiologists for their research: communicate to understand their needs, influence their decisions, and prioritize projects
- Transferred research objectives to analytical plans by partnering with researchers
- Extracted patient visit records, built time-series statistical model, and identified the positive relation between rain fall and hospital visits using SAS and R language.