Â§ SAS Programmer with 6+ years of experience in programming, analyzing and reporting in various Pharmaceutical industries using SAS on Windows environment. Â§ Efficient knowledge in Drug Development Process with strong experience of analyzing and reporting in pre-clinical and clinical trials that is phase I, II, III and IV (post-marketing) studies of clinical trial data. Â§ Experience in analyzing clinical protocols, Case Report forms (CRF’s), Annotated CRF’s, ICH and GCP guidelines Trained in Good Clinical Practice (GCP), Regulatory Compliance and FDA Guidelines.
Â§ Created CDISC SDTM and ADAM datasets according to specifications andHighly skillful in Clinical Trials Data like Demographic data, Adverse Events (AE), Laboratory data (Lab data), Vital Signs etc., based on SDTMIG and ADAMIG. Â§ Involved in Clinical Data Analysis and preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Standard Operating Procedures (SOPs) and departmental guidelines.
Â§ Strong knowledge on Base SAS, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macros, SAS/ODS and SAS/SQL in Windows Environment. Â§ Optimized performance using Data Validation and Data cleansing on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE. Â§ Generate reports using PROC REPORT, DATA_NULL_ and PROC TABULATE for customized report writing. Â§ Expertise in producing RTF, PDF, HTML files using SAS ODS facility. Â§ Experience in extracting, manipulating data, and creating Data Sets from various sources like Excel, flat files, Oracle database, Access database using PROC IMPORT techniques. Â§ Excellent ability in problem solving, data analysis, complex reports generation. Â§ Proficiency in understanding of Study Protocols, SAP (Statistical Analysis Plan), and CRF. Â§ Exceptional problem solving skills with excellent communication skills, detail oriented, organized, enthusiastic to work in a fast paced and team oriented environment.
Â§ Certified Base/SAS programmer for SAS9, Regulatory Affairs Certified (RAC). Â§ SAS Tools: SAS V9/9.2, SAS/BASE, SAS/ACCESS, SAS/SQL,SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/REPORT, SAS/ODS. Â§ Databases: Clinic-Trial, SQL server, Microsoft Access. Â§ Operating Systems: Windows98/2000/XP Â§ Languages: SAS, SPSS. Â§ Office Tools: MS-OFFICE, Word, Excel, PowerPoint, HTML. Â§ Core Competencies: Statistical programming, Clinical Trials, Data Analysis, Reports Development.
Express Scripts, Inc., St.Louis Missouri Oct ’12 -Till Now
Sr. SAS programmer
Express Scripts is one of the largest Pharmacy Benefit Management organizations in the States. This is a full service Clinical Research Organization provides Phase I/II to IV clinical development services to pharmaceutical, biotechnology and medical device companies in most major therapeutic areas.
Responsibilities: Â· Created CDISC SDTM and ADAM datasets according with specifications. Â· Generated VAD‘s (analysis data sets), Tables, Listing and Figures by using CDARS system. Experienced in demotion of system level macros to protocol level using CDARS. Â· Extracted data using SAS Web tools. Â· Developed efficient, well documented, readily comprehensible, modifiable and reusable SAS programs using Base SAS and SAS Macros. Â· Worked with Data Cleaning and data validation on the work developed by other programmers in compliance with 21 CFR part 11 regulations. Â· Developed and used SAS MACROS programs to generate reports, tables and listings for clinical and bio-statistical review. Also used SAS MACROS to create new programs and modified existing SAS programs to make them portable as well as consistency of results.
Â· Used PROC GLM, PROC TTEST, PROC MIXED, PROC LIFTEST, and PROCCORR for Efficacy analysis.
Â· Used efficient programming techniques to produce QC derived datasets.
Â· Created specifications for demographic and adverse events datasets in accordance with Statistical Analysis Plan and Protocol.
Â· Validated Data and Performed quality check control of the displays and datasets according to the different QC levels.
Â· Generated various RTF, PDF files using SAS ODS system, exported and imported data from Excel files using PROC IMPORT and PROC EXPORT.
Â· Restructured SAS datasets using PROC TRANSPOSE for the analysis.
Â· Developed reports using PROC REPORT, PROC TABULATEandDATA _NULL_.
Â· Performed Quality Control and Quality Assurance on the work performed by others.
Environment:SAS 9.2, SAS 9.1.3, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ACCESS, Enterprise Guide.
Quintiles, KSMay â€˜11 to Oct â€˜12
Sr. SAS programmer
Â· Headed SDTM mapping for numerous studies across a wide range of therapeutic areas.
Â· Performed CDISC SDTM Mapping of variables to make the raw data conform to the SDTM model. Â· Developed specs to map a clinical study in compliance with SDTMIG V3.1.2 and annotated CRF accordingly. Â· Established domain models according to SDTM specs and also created new domains that are CDISC compliant. Â· Experience with SAS Programs for Edit Checks, validated listings and summary tables. Â· Efficiently produced Statistical summary Tables, Figures, and Listings (TFL’s) in accordance with standards and validation procedures. Â· Validated reports using independent programming. Â· Acted as liaison between statisticians and validation programmers. Â· Represented Statistical programming team in review meetings.
Â· Authored the mapping of pharmacokinetic data into SDTM domains PC and PP.
Â· Developed Listings, Tables and Graphs to access Safety and Efficacy during Phase I-III trials.
Â· Extensively used various PROC SQL Procedures for merging, determining counts and to create macro variables. Â·Generated the tables – Demographic data tables, Adverse Events (AE) tables, Serious Adverse Events (SAE) tables, Laboratory data tables etc.
Environment: SAS 9.2, SAS 9.1.3, SAS/BASE, SAS/MACRO, SAS/ACCESS, MS-Access, MS-Excel, ORACLE, Windows XP.
Spectrum Pharmaceuticals, Irvine, CAFeb â€˜09 to May â€˜11
SAS Clinical Programmer The client wanted to streamline the production of clinical trials. The main aim of this project was to speed up the clinical trials phases, generate clinical trials reports more accurately for FDA regulations and reduce the R & D costs of the organization.
Â·Extensively involved in creating SDTM and ADaM datasets following CDISC standards.
Â· Involved in the modification of Tables and Datasets in Phase II-III study according to the requirements of the statisticians. Â· Interacting with Data managers, Statisticians and CRA’s in clinical research and development of individual will provide programming support to the Processing of clinical data.
Â· Used SAS Base Procedures PROC FREQ, PROC TABULATE and PROC MEANS to validate current results with expected results. Â· Used SAS Macros for generating tables and listings. Â·Extensively worked on PROC REPORT, PROC TABULATE and DATA_NULL_ programming to generate the reports for the purpose of production as well as validation of outputs. Â· Extracted data from Oracle data base using SQL Pass through facility. Â· Validated all the tables and listing using validation rules. Â· Worked with validation team to validate the applications compliance with 21 CFR part 11 regulations. Â· Produced safety and efficacy reports in PDF formats. Â·Created analysis datasets, graphs, tables and listings for High Priority requests. Â· Develop programs to generate listings and summary tables for Clinical Study Reports as described in the Statistical Analysis Plan. Â· Generated the table for Integrated Summary of Efficacy (ISE) and Safety (ISS).
Â· Involved in problem solving, data analysis, and complex report generations. Â· Developed various forms of out putslike RTF, PDF, HTML files using SAS ODS facility. Â· Experienced in code checks with Automated Query generation and validate clinical datasets. Â· Created ad-hoc reports using SAS. Environment:SAS/Base 9.1.3, SAS/Macros, SAS/Stat, SAS/Graph, SAS/ODS, SAS/SQL, SAS/Connect, SAS/Access, MS-Excel, MS-PowerPoint, UNIX and Windows NT.
Genzyme Corporation, Boston, MAJan â€˜07 to Jan â€˜09
Responsibilities: Â·Programming in SAS for analyzing data and producing tables and listings for safety and efficacy analysis in specified formats for submission or for other purposes. Â· Created CDISC SDTM and ADAM datasets according with specifications. Â· Developed specifications/ programs for Derived datasets based on the requirements from the SAP. Â· Enumerated a list of physical and logical problem areas in datasets across studies for ISS and ISE
Planning and contributed to the analysis plan. Â· Used sorting, merging and transpose techniques on input datasets for Data Preparation and to get the required output. Â· Developed SAS Macros to create tables, graphs and listings for Clinical Study Reports and regulatory submissions. Â· Used SAS Base procedures such as PROC SUMMARY, PROC REPORT and SAS GRAPH for designing statistical summary tables and graphs. Â· Designed, created and maintained the database, as well as developed and generated reports, tables and listings using SAS. Â· Used Output Delivery System (ODS) facility to write safety and efficacy reports directing SAS output to RTF listings, tables and reports. Â· Extensive use of the SAS Macro facility to write routine monthly reports and to create tables, graphs and listings. Â· Involved increating Annotated CRFs and Transport datasets in .XPT format for client.