Statistical Programmer III Resume Example The Parkinson's Institute

STATISTICAL PROGRAMMER III

Professional Summary

M.S. in biostatistics with extensive statistical analysis and programming experience seeks challenging opportunity to work as a SAS Programmer/ Analyst in a dynamic work environment SAS Programmer with 10+ years of experience in the Healthcare and Pharmaceutical Oncology Industry Programming Support for NDA submissions, FDA/EU requests, CSR, 120-Day MCL oncology safety update analysis, PMR analysis, graphs and various tables. Good working knowledge of FDA regulations as related to clinical programming processes. Good experience with CDISC mapping of raw data to SDTM and SDTM to ADAM. Knowledge of statistical principles underlying clinical trials and experience in analyzing safety and efficacy data for Phase (I -III) of clinical trials Good knowledge of drug development, EDC, MedDRA, and WHODRUG. Communicates concepts, ideas and results to develop solutions to questions raised by clinicians and others. Gynecologist and Obstetrics in Hai Dian Hospital at Beijing of China.

Core Qualifications

SAS, STATA, S-plus, C, JAVA, SQL
Statistical software: SAS, STATA, SPSS, S-plus, R, Winbugs; some experience with Minitab
Database management systems: Microsoft Access, SQL
Computing Platforms: Unix (Linux), DOS/Windows
Microsoft office: Word, Access, Excel, PowerPoint
Others: LaTex, PASS
Langue:
Chinese
English
PAPERS:
MK. Gould, Ellen M. Schultz, Todd H. Wagner, Xu X Racial and ethnic disparities in the use of positron emission tomography among patients with non-small cell lung cancer in the Cancer Care Outcomes Research and Surveillance study
C Clément-Duchêne, Xu X, S.L. Gomez, E.T. Chang, D.W. West, H. Wakelee, MK. Gould Survival among never and ever smokers with lung cancer in the Cancer Care Outcomes research and surveillance consortium study
Julie C Weitlauf, Rudolf H Moos. Xu X Impact of Posttraumatic Stress Disorder on Receipt of Cervical Cancer Surveillance
Maheen M. Adamson, Viktoriya Samarina, Xu X The impact of whole brain size on flight simulator performance in aging pilots varies with aviation training and years of education
Maheen Adamson, Quinn Kennedy, Susan Duong, Xu X Predicting flight simulator performance with baseline brain volumes, expertise and age in order pilots at rish for alzheimer's disease
Julie Weitlauf, Rudolf Moos, Xu X Receipt of Guideline Concordant Cervical Cancer Surveillance: Impact of Posttrumatic Stress Disorder
Stone RA, Xu X, Validation Statistical Issues in Racial/Ethnic Disparities Research
Jaspreet Bar, Xu X, AM Kilbourne , Medical Comorbidities in Veterans with Serious Mental Illnesses: A Comparison with National Data
JE Zeber, LA Copeland, Xu X, Patient Perceptions of Therapeutic Alliance, Ethnicity, and Association with Medication Adherence
LA Copeland; JE Zeber; Xu X; IM Salloum; CB Good ; MJ Fine; AM Kilbourne, Treatment Adherence and Illness Insight in Veterans with Bipolar Disorder
AM Kilbourne, CB Good, JE Zeber, LA Copeland, Xu X, MJ Fine, HA Pincus, Race, Polypharmacy, and Metabolic Risk Factors in Veterans with Bipolar Disorder
PUBLICATION:
Kilbourne AM, Salloum IM, Dausey D, Cornelius J, Conigliaro J, Xu X, Pincus HA. Quality of care for substance use disorders in patients with serious mental illness (Journal of Substance Abuse Treatment, Volume 30, Issue 1, Pages 73-77)
Amy M. Kilbourne, Jaspreet S. Brar, Rebecca A. Drayer, Xu X, Edward P

Experience

Statistical programmer III
June 2013 to Current

Lead programmer for the first FDA approved BTK Inhibitor indication in a Phase II clinical trials Work on urgent FDA submission requests Participate in 120- Day safety update submission.
Participate in ISS-EU submission.
Coordinate with CDM, Biostatic, and BioClinica to check EDC database.
Recognizes inconsistencies and initiates resolution of data problems.
Instruct and check mapping of tumor response data and extra nodal image data to SDTM and SDTM to ADaM Leading and corporate with CRO to complete all TLGs for PMR and extra nodal statistical analysis.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
Participate in multiple phase I-II clinical trials and submission.
Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
Review Data Management Plan, Data validation plan and edit check specifications Assist in preparing clean database, including generating queries and resolving verification discrepancies.
Managing data from different source Acts as a liaison between statistical programming, subcommittees and project teams as needed.
QC summary tables, data listings and figures for in-house analyses of study data or publication using SAS standard coding practices.
Help to prepare protocol which describes the purpose the study, and hypothesis for the study Assistant for documenting statistical analysis plan that will be performed on the clinical data Develop clinical data management plans and quality assurance plans that will deliver accurate, consistent and quality clinical data Statistical programmer at VA Center for Health Care Evaluation and Stanford Aging clinical research center.

September 2007 to May 2013

Pull and create SAS datasets from difference source and format: from SQL server, Use Proc SQL and ODBC to manage data, from ASCII text flat file, from case report form, from an electronic data capture system.
Export data file, convert .txt and .xls raw data into SAS Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listing and graphs for clinical study Worked with different clinical trials data such as demographics, Event Data, Lab, ECG, Pharmacy data, Vital signs and so on.
Execute analyses specified in the Statistical Analysis Plan.
Perform descriptive statistics measures of central tendency and variability.
Cross-tabs, and frequencies; and inferential statistics (e.g., t-test.
ANOVA, GLM, multivariate analysis, linear and non-linear regression modeling and repeated analysis, and longitudinal data analysis, propensity score analysis, survival analysis) Variety experience on difference area of clinical research: oncology (cancer) research ( lung cancer and cervical cancer), cardiology (compare commonly used drugs, compare cardiology verse primary visit on patient with atrial fibrillation or atrial flutter), brain image research Collaborate with doctors from Gilead and Medtronic to look at effectiveness and safety of atrial fibrillation therapies.
Cardiovascular drugs endpoint studies to look survival rate, drugs adherence.
Collaborating with data manager, postdoctoral fellows, doctors , and professors and emphasis on data management and analysis.

Data analyst
August 2006 to October 2007 The Parkinson's Institute

Designing and implementing a data cleaning system; resolve data inconsistencies; preparing datasets.
Developing standard reports to provide detailed and aggregate summaries.
Analysis of epidemiological studies of Parkinson's disease and other movement disorders.
Experience with DataEase 6.5, SAS SQL, SAS Macro and SPSS programming and SPSS macro.

October 2004 to August 2006 Biostatistician at CHERP VA Pittsburgh Healthcare System

Manipulate huge data (over millions of records) using SAS(arrays, macros) from disparate data sources (including National Death Index, Austin data warehouse, Vista data warehouse, VA EPRP).
Develop programs as necessary to prepare data displays and perform statistical analyses.
For assigned clinical development projects, provide power calculation (use PASS), generates study randomization, draw samples from survey dataset.
provide statistical review of program output, tables, figures, and listings resulting from the specifications mathematical modeling.

Education

M.S : 5 2004 Biostatistics, University of Iowa

Certifications

Post Cardiovascular Disease and Metabolic Risk Factors in Male Patients With Schizophrenia, Schizoaffective Disorder, and Bipolar Disorder(The Academy of Psychosomatic 2007 48: 412-417) Bean-Mayberry B, Brucker N, Bayliss N, Xu X, Mor M, Yano E, Fine M. "Effect of Gender and Race on Receipt of Pneumococcal and Influenza Vaccines in VA." Journal of General Internal Medicine 2006;21(Suppl 4):44. [Published Abstract] Bean-Mayberry B, Elizabeth Yano, Maria Mor, Nichole Bayliss, Xu X, Michael Fine. Does Sex Influence Immunization Status for Influenza and Pneumonia in older veterans? Michael Gould, Ellen Schultz, Todd Wagner, Xu X, Sharfun Ghaus. Disparities in lung cancer staging with positron emission tomography on the Cancer Care outcomes research and surveillance (CanCors) study. Mintu P Turakhia, Donald D Hoang, Xu X, Susan Frayne, Felix Yang, Ciaran S Phibbs, Claire T Than, Paul J Wang, Paul A Heidenreich. Differences and trends in stroke prevention anticoagulation in primary care vs cardiology specialty management of new atrial fibrillation: The Retrospective Evaluation and Assessment of Therapies in AF (TREAT-AF) study. Maheen M Adamson, Viktoriya Samarina, Xu X, Virginia Huynh, Quinn Kennedy, Michael Weiner, Jerome Yesavaga, Joy L Taylor, The impact of brain size on pilot performance varies with aviation training and years of education

Skills

ad, C, Chinese, draw, data management and analysis, Data analysis, Data Management, data warehouse, Database management, database, DataEase 6.5, Designing, DOS, edit, English, graphs, image, JAVA, languages, Linux, Macros, Managing, Access, Microsoft Access, Excel, Microsoft office, PowerPoint, Windows, Word, Minitab, modeling, ODBC, ODS, coding, programmer, Programming, PUBLICATION, Quality, quality assurance, Research, safety, SAS, SPSS, SQL server, SQL, STATA, Statistical Analysis, statistics, tables, Unix, Validation, Vista, Wang

Resume Overview

Create a job alert for [job role title] at [location].

About About

Help & Support Help & Support

Languages Languages

Customer Service Customer Service

Statistical programmer III Resume Example

Resume Score: 90%