SUMMARY:

• Over 7 years of extensive SAS programming experience in pharmaceutical and CRO Industries.
• Expertise in BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/PC and SAS/ODS in windows and UNIX environments.
• Experience in working on Phase I, Phase II, Phase III and Phase IV.
• Extensive experience in Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (lab data), physical and vital signs and Audit Trials.
• Good knowledge of FDA ICH - GCP and clinical terminology.
• Good knowledge of CDISC standards like SDTM domains and AdaM.
• Experience in regulatory environment and have up-to-date experience with rules and regulations on submissions.
• Extensive experience of using MedDRA for regulatory submissions.
• Experience in creating the analysis datasets and converting SAS datasets into CDISC SDTM.
• Extensively 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.
• Thorough knowledge in SAS programming, merging SAS Data set, Macro Facility, Preparing data, Producing reports, SAS formats, SAS functions, SAS statements, SAS Informats, storing and managing data in SAS files and involved in all four phases of clinical trials.
• Proficient in various SAS report generating procedures like PROC REPORT, PROC FREQ, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC TRANSPOSE and PROC SQL.
• Extensive knowledge of statistical procedures like PROC ANOVA, PROC REG, PROC CORR, PROC GLM, PROC MIXED, PROC MEANS and PROC UNIVARIATE.
• Knowledge of CRF-Annotation with respect to various database designs
• Conducting, documenting and reporting computer validation inspections in compliance with 21 CFR Part 11, data transmission and integrity check for the existing and in-house Clinical Trial Systems.
• Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.
• Experience in Ad-hoc Programming for Clinical and Data Management Departments.
• Exceptional problem solving skills for delivering useful and prudent solutions. Always keen and eager to face up to challenges by means of novel and innovative ideas.
• Excellent skills in diagnosing and avoiding errors, understanding and enhancing output to furnish reports.
• Excellent oral and written communication skills. A quick learner with an eye for detail and excellent analytical and quantitative skills.
• Always emerged to be an excellent team player with strong leadership skills.

PROFESSIONAL EXPERIENCE:

Confidential, TX

SAS Programmer

Responsibilities:

• Analyzed the Clinical data for Phase II and Phase III.
• Generated SDTM v3.1 data sets for AE (Adverse Events), MH (Medical History), DM (Demographics), PE (Physical Examination), VS (Vital Signs), SC (Subject Characteristic), LB (Laboratory).
• Carried out semi-automated conversion of non CDISC compliant datasets by using SAS MACRO functions. Dataset columns were converted into rows to support CDISC naming conventions.
• Generated Tables, Listings and Graphs using various procedures like Proc Freq, Proc Report, Proc Tabulate, Proc Univariate, Data null, and Proc Gplot..
• Created and extracted Oracle tables from SAS and within Oracle by using PL/SQL.
• Generated analysis datasets with derived variables and performed statistical analysis on data as per the SAP.
• Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard and review CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.
• Created, validated, documented and maintained libraries of SAS application programs, formats and macros.
• Developed SAS programs for Edit checks.
• Involved in validating other programmers code.
• Developed utility macros for standard reports and validations.Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Handled Dropouts and Missing Data by using traditional approach of generating Last-Observation-Carried-Forward (LOCF) data on Visit-wise data.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, Data Null, and Univariate.
• Developed regression equation using PROC REG, PROC GLM and used PROC CORR to test the association between the variables.
• Produced accurate, precise tables and graphs for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part 11, FDA and other regulatory compliance.
• Generated HTML, RTF, PDF reports using ODS statements.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Successfully handled multi-projects /tasks at a time.

Environment: SAS (9.2), SAS/BASE, SAS/MACROS, SAS/ODS, SAS/STAT, SAS/ACCESS, SAS/SQL, Excel/Access, Windows - XP.

Confidential, NC

Clinical SAS Programmer

Responsibilities:

• Generated summary tables, graphs and data listings for interim and final analysis on Epidemiological data.
• Programmed datasets in CDISC standards - SDTM, using mapping specifications, define specifications from CRF data and managed SDTM database for several protocols.
• Handled dropouts and missing data by following the conventional approach of Last Observation Carried Forward (LOCF) and Best Observation Carried Forward (BOCF) on visit-wise data.
• Generated tables and listings for - Vital signs, clinical laboratory evaluations, disposition of subjects, concomitant therapy, malignancies, infections and protocol violations.
• Performed the Testing (UAT) process on SDTM domains at different levels.
• Experience in creating user friendly macros and replacing the code with macros to reduce code redundancy.
• Performed Categorical data analysis on parametric and non-parametric data using Proc FREQ and Proc CATMOD on the analysis datasets.
• Performed tests of association (Pearson, MH-chi), correlation and regression on the analysis datasets using different statistical procedures.
• Worked with Bio statistician to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM, and T test.
• Resolved requests issued from the study teams on SDTM domains.
• Imported/Converted randomization data files from Excel, Word, and Text based data files into SAS data sets for analysis.
• Produced TLG’s for Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).
• Performed QC, Data validation and edit checks using various procedures and SAS macro facility.
• Generated Adhoc Audit Trial Listings to Data Management in the form of MSWORD (DOC) files, as per the request.
• Created datasets, reports, summaries using Proc SUMMARY, Proc REPORT, Proc UNIVARIATE and Proc TABULATE.
• Generated interim reports in the form of MS-WORD (DOC) files, as per the request.
• Assisted statisticians in generating frequency distributions and to present the results in histograms, box-plots, pie-chart and scatter-plots using the graphical procedures.

Environment: SAS (8.2), SAS/MACROS, SAS/ODS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL, Excel/Access, Windows - XP.

Confidential, PA

Clinical SAS Programmer

Responsibilities:

• Responsible for database management and SAS programming for producing Reports, Summaries, Listings, Graphs for statistical analysis and reporting.
• Participated in Statistical Analysis Plan (SAP) along with other Bio-Statisticians as a part of Data Management Plan.
• Retrieved tables from Oracle Clinical database with PROC SQL.
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.
• Involved in analyzing Pharmacokinetics and Pharmacodynamics Property of the drug using PK/PD Parameters.
• Produced quality customized reports by using Data Null, PROC TABULATE, REPORT and SUMMARY, SQL and also provided descriptive statistics using PROC Means, Frequency and Univariate.
• Conducted and generated the Regression, Correlation studies and Analysis of Variance (ANOVA).
• Involved in preparation of Statistical Considerations sections, sample size calculations, interim looks, randomizations, and study design recommendations.
• Interacted with Clinical, Regulatory, and Data Management colleagues to coordinate collection and reporting of clinical trial results.

Environment: SAS/ BASE, SAS/OR, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/Access, Oracle, Windows NT, UNIX

Confidential

SAS Programmer Analyst

Responsibilities:

• Involved in providing programming support for Clinical Data Coordinators and Statisticians.
• Produced efficient datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE.
• Prepared the data according to client requirements using data management procedures such as If/else statements, Do groups, Where statements, and Arrays.
• Used infile statement options to control processing when reading raw data files in SAS.
• Developed SAS programs for Edit checks.
• Generated HTML, Listings and reports for presenting the findings of various statistical procedures using procedures like PROC REPORT, PROC PRINT, PROC FREQ and also the SAS ODS.
• Provided analysis support and generated Datasets and Reports for pharmaceutical studies.

Environment: Windows2000, SAS (8.2), SAS/Macro, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/SQL.

TECHNICAL SKILLS

Operating System: Windows, UNIX

Database: Oracle Clinical, Sybase, DB2

SAS Skills: SAS/BASE, SAS/STAT, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/SHARE, SAS/ACCESS and SAS/CONNECT

SAS Procedures: PRINT, MEANS, REPORT, SORT, FREQ, TABULATE, TRANSPOSE, IMPORT, EXPORT, SQL, COMPARE, REG, CORR, ANOVA, GLM, GPLOT.