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Clinical SAS programmer

Location:
Germantown, MD
Posted:
March 14, 2018

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Resume:

Song Li

***** ******** ***** ***** *****: 240-***-****

Germantown, MD 20874 Email: ************@*****.***

Objective

To seek a position to apply my extensive knowledge, profound skills and experience in SAS data analysis programming

Professional Summary

20 years of programming experience in SAS/Base, SAS/Stat, SAS/Macro, SAS/SQL, SAS/Graph and SAS/ODS.

20 years of experience in statistic analyzing clinical trial data and epidemiology data

Strong academic training and knowledge in statistics and computer software skills

Ability to work effectively both as an individual and in a team environment.

Education

M.S., Statistics, Iowa State University, 1997

B.S., University of Science and Technology of China

Relevant Experience

Westat

1600 Research Blvd.

Rockville, MD

Senior Data Analyst 2007 to Present

SAS Programmer 1998 to 2006

Data analysis:

Developed SAS programs, created variety analytic datasets and generated tables, listings and figures based on the SAP (statistical analysis plan)

Created the DSMB (data safety monitoring board) reports submitted to FDA.

Analyzed the data using various statistical procedures like PROC GLM, LIFETEST, LOGISTICS, MIXED, ANOVA, Npar1way, FREQ, T-TEST, etc.

Developed customized reports using PROC REPORTS, PROC TABULATE or other procedures to create PDF, RTF or spreadsheet formats reports.

SAS macro developing:

Developed a SAS macro product based on a statistic method provided by a senior statistician to estimate and calculate survey score variances and other components for the National Committee for Quality Assurance.

Built reusable SAS macros for generating the common tables such as Adverse Event, Vital Signs and Laboratory tables and listings

Developed reusable SAS Macros to verify, QA/QC data, and delivery data package.

Data processing/reporting:

Extract data from OC and other database utilize the Proc SQL and Proc Import.

Setup and accomplished study site performance reports package to monitor data quality including missing visits report, visits outside visit windows, delinquent CRF form, and data reconciliation reports.

Human subject data de-identification procedure including randomization ID, converting sensitive data and data reconciliation procedure.

Generating variety data reports to quality assure the data process included the reports of the advance events, drug compliance, subject accrual, etc.

Others:

Developed a programming validation plan which provides the information for planning, performing and documenting analytic programming for a project.

Performed peer reviews, which included reviewing program code, test run, confirming accuracy of results and client style guidelines and SOP guidelines.

Reviewed and provided feedbacks for Statistical Analysis Plans, Clinical Data Management Plan and Case Report Forms development and Annotation.

Databases:

Working data from Oracle Clinical, Smile CDR, OpenClinica and Excel/CSV Spreadsheet.

Relevant Major Projects Experience

Adolescent Medicine Trials Network - Evaluates behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in adolescents with and at risk for HIV infection.

Responsibilities:

Generating the 1) SAP (statistical analysis plans) tables and graphs, 2) DSMB (data safety monitoring board) reports and 3) AE (advance events) reports.

Working with the site monitoring managers and database managers to monitor and quality control data collection by creating performance report package to identify the delinquent CRF form, visits outside visit windows and data reconciliation reports.

Reviews statistical analysis plans, provided and discussed potential analysis issues with statisticians.

Reviews the CRFs during protocol development and provide feedbacks from programming point view.

Used Output Delivery System (ODS) facility to write custom SAP and DSMB reports in PDF, RTF and HTML formats.

Working with the data management team and system team to develop the SAS Macros to automatically generate codebooks and data descriptive documents for data delivery.

Phase IV Combination Therapy Analysis (Asthma) - Evaluate therapeutic options for the treatment of asthma. A database of 4,000 patients was analyzed to examine the use and costs of health care resources and medications.

Responsibilities:

Worked with a senior epidemiologist and senior statisticians to performance data analysis by utilizing SAS/Stat such as GLM, LOGISTICS and T-test.

Natural History of Post-Transfusion Non-A, Non-B Hepatitis - A three-phase collaborative study involving 15 clinical centers. This nonconcurrent prospective cohort study evaluated the serious, long-term sequelae of transfusion-acquired hepatitis. Approximately 1,800 subjects from previous transfusion studies were selected and traced.

Responsibilities:

Worked with a senior epidemiologist to analyze data and provided the SAP tables.

Worked with protocols data management staff to secure the data is accurate and medical coding is appropriate.

Developed reusable SAS Macros to verify data, create tables, graphs, and listings for inclusion in clinical study reports, and regulatory submissions and maintained existing ones.

NINDS Pilot Therapeutic Trials Network Clinical Operations Center - This center was established to increase the speed with which potential treatments for neurological diseases move from preclinical to clinical studies, while ensuring broad participation and representation of different populations and diseases.

Responsibilities:

Performing of the database updating and maintaining.

Generating variety data reports to quality assure monitoring the data process included reports of the advance events, drug compliance, accrue, etc.

Worked with statisticians to generate the SAP tables included Dose Limiting Toxicity, Adverse Events, Drug Relationship and so on.

Phase IV Drug Effectiveness, Patient Satisfaction and Quality of Life Outcomes – These two phase IV post-marketing studies examined the effectiveness and quality of life associated with a marketed anti-infective agent. Questionnaries were administered to 65,000 patients being treated for respiratory infections in managed care and private practice.

Responsibilities:

Developed reports using PROC REPORTS and PROC TABULATE.

Generated codebooks and data descriptive documents. Accomplished management and verification of different type data source/components for data delivery.

Pediatric and Maternal HIV Clinical Trials Network Coordinating Center – A clinical trials network in more than 80 multicenter clinical trials of therapies for HIV-infected children, adolescents, women, and pregnant women seen at clinical centers in the United States, Puerto Rico, the Bahamas, and Brazil.

Responsibilities:

Reviewed the case report forms, data validations, and data quality plans.

Performed peer reviews, which included reviewing code, confirming accuracy of results, conforming to client style guidelines and SOP guidelines.

References upon request.



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