SUMMARY

• SAS Programmer with 7+ years of experience in providing technical and statistical solutions for integrating, analyzing, validating and reporting clinical trial data in Pharmaceutical and CRO industries.
• Proficient with SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPHS, SAS/ODS, SAS/CONNECT etc.
• Good understanding of Drug Development Process in Phase I, II and III, clinical trial practices, procedures and methodologies, study protocols, case report forms (CRF/eCRF) and statistical analysis plans (SAP).
• Good knowledge of ICH - GCP Guidelines, NDA, IND, CDISC standards, GPP and FDA- 21 CFR Part 11.
• Familiar with standard Dictionaries such as MedDRA and WHODRUG.
• Extensive experience using SAS functions, and procedures such as PROC (SORT, FORMAT,FREQ, REPORT, TABULATE, TRANSPOSE, SUMMARY, APPEND, DATASET, COPY, ANOVA, GLM, TTEST, MEANS, GPLOT, GCHART, REG, TRANSREG, CORR, LOGISTIC, UNIVARIATE) etc.
• Expertise in creating and validating SDTM datasets, analysis datasets (ADaM), generating Reports, Tables, Listings, Graphs/Figures (TLG/F) and Summaries by consistently applying standards and complying with regulatory requirements, corporate and departmental SOP’s and work practices.
• Knowledge of CRF-Annotation with respect to various database designs.
• Experienced in generating Ad-hoc reports.
• Extensively used SAS/ODS procedures to generate Reports.
• Experienced inEdit check programming to identify potential data issues and resolve them with analytical and problem solving approach.
• Working knowledge on SAS Macros for generic coding and reusable modules.
• Involved in the process of generating Clinical Study Report (CSR), Integrated Summaries of Safety (ISS) and Efficacy (ISE) and file transportas part of CRTfor FDA submission.
• Effective communication, presentation, interpersonal and organization skillsand very adaptable to a fast-paced team environment.
• Proficient in handling multiple projects at one time within tight timelines.
• Hard-working and competent, and always willing to learn.

TECHNICAL SKILLS

SAS Tools: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/CONNECT, SAS Enterprise guide.

Software: SAS, MINITAB, R.

Database: Oracle Clinical, SQL Server 2000, MS Access

Operating Systems: Windows 95/98/2000/vista/XP/ windows 7/windows 8, Unix

Core Competencies: Statistical Programming, Clinical Trials, Data Analysis, Report Development

Other Technologies: Microsoft Office Suite (Word, Excel, PowerPoint, Access).

PROFESSIONAL EXPERIENCE

Confidential, NC

Responsibilities:

• Programmed, analyzed, validated and generated reports, listings, tables and summaries for Phase II-III of Clinical Trial data.
• Created SDTM and ADaM datasets by following the CDISC Standards, Protocol and SAP.
• Developed QC programs to confirm CDISC SDTM compliance on final converted datasets.
• Performed categorical and exploratory statistical data analysis on research data using various statistical procedures like PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TRANSPOSE, PROC LOGISTIC and PROC GENMOD.
• Responsible for the proper coding, documentation and validation of SAS programs/macros/procedures.
• Performed SQL queries for generating tables and getting the population counts.
• Used ODS trace on/off and ODS OUTPUT to generate required tables for various ad-hoc reports.
• Developed general utility Macros and modified the existing Macros as per the requirement.
• Generated p-values using chi-square, T-test, Fishers exact method.
• Produced customized reports by using PROC PRINT, PROC TABULATE, PROC REPORT, and PROC SUMMARY for reporting on safety and efficacy.
• Generated Kaplan-Meier Tables and Graphs using PROC LIFETEST.
• Created tables for ad-hoc requests and submission for all areas like safety, efficacy, lab, demographics etc.
• Involved in creating transport files for electronic submissions to the FDA.
• Involved in generating the IND reports (ISS & ISE) as per the requirements from Statistician and SAP.
• Ensured datasets and programming code meet CDISC, company standards and are consistently structured to permit efficient programming and reporting.
• Reviewed SAS programs and output produced by other team members for detecting deviations from the study protocol and for logical errors.
• Worked with Biostatisticians and Data Management team in resolving data issues.

ENVIRONMENT: SAS/BASE, SS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/MACRO,SAS/ACCESS, Windows XPMS Excel/Word/PowerPoint.

SAS programmer

Responsibilities:

• Involved in programming, validating and generating reports forphase II and phase III data.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools: SAS/Base, SAS/Macro and SAS/Graph.
• Developed safety tables documenting adverse events, vital signs, laboratory measurements and concomitant medication intake.
• Prepared efficacy and safety summary reports with tables, listings and graphs and statistical measurements.
• Produced customized reports using PROC TABULATE, REPORT, and PROC SUMMARY and also provided descriptive statistics using various statistical procedures.
• Conducted regression, correlation studies and analysis of variance by using PROC CORR,PROC GLM.
• Used CDISC SDTM to convert the tabulations in company’s standards to FDA standard tabulations.
• Involved in documentation of newly developed SAS code and participated in testing/validating SAS code with specifications
• Participated in team meetings and coordinated with team members and managers to meet project deadlines

ENVIRONMENT: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, Oracle, UNIX and Windows.

Confidential, CA

SAS Programmer

Responsibilities:

• Created SDTM and ADaM datasets by following the CDISC Standards
• Created analysis datasets and generated Tables, Listings and Graphs.
• Produced data listings, summary tables and graphics using analysis datasets for interim and final analysis and publications.
• Extensively used PROC Print, PROC Tabulate and PROC Report to create reports and used SAS/ODS for generating reports in different formats.
• Validated the Analysis datasets, Tables and listings by parallel programming specified in Statistical analysis plan (SAP).
• Written and QC SAS programs to generate appropriate listings (patient profiles) and reports to support data cleaning.
• Developed general utility Macros and modified the existing Macros as per the requirement.
• Involved in generating the IND reports (ISS & ISE) as per the requirements from Statistician and SAP.
• Generated the Datasets and TLF's for the Regulatory Submissions.
• Generated Kaplan-Meier Tables and the Graphs using PROC LIFETEST.
• Created tables for ad-hoc requests and submission for all areas like safety, efficacy, lab, demographics etc.
• Ensure the proper and timely delivery of ad-hoc reports as required.
• Represented Statistical programming team in review meetings.

ENVIRONMENT: SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/CONNECT, UNIX and Windows, MS Excel/Word/PowerPoint.

Confidential, TX

Statistical Programmer Analyst

Responsibilities:

• Worked on Phase I, II and III of Clinicaltrial studies and involved in processing and managing the data.
• Extracted data from Oracle Clinicaldatabase into SAS datasets and converted existing raw data into CDISC standards and reviewed CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.
• Ensured that client data converted to CDISC SDTM domain models was in full compliance with current SDTM requirements
• Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Format, Functions and conditional statements.
• Generated reports, tables, and summaries for Integrated Summaries of safety (ISS), Efficacy (ISE) for FDA submission.
• Worked with the complex datasets to extract customized reports of theClinical trial data such as Demographic data, Medical History data, Adverse events (AE) Data, Serious Adverse Events (SAE), Event Assessment Data Laboratory Data.
• Developed and analyzed key performance indicators relevant to emerging needs using PROC SORT, PROC MEANS, PROC FREQ, PROC TABULATE, PROC REPORT and PROC SUMMARY.
• Worked with statistical quality assurance group and program validation for each project.

ENVIRONMENT: SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/CONNECT, UNIX and Windows, MS Excel/Word/PowerPoint.

Confidential

Clinical SAS Programmer

Responsibilities:

• Created new or modify SAS programs to load data from different databases and created study specific datasets, which are used as source datasets for report generating programs.
• Cleaned, validated, and managed various Clinical trial datasets, and handled missing values.
• Conducted statistical analyses using SAS/STAT including PROC MIXED, PROC FREQ, PROC LIFETEST, PROC PHREG, etc.
• Developed numerous ad-hoc SAS programs to create summaries and listings.
• Used PROC GPLOT to create graphs in SAS.
• Generated interpretive charts, tables and reports in accordance with regulations including patient demography, discontinuation, and adverse events.
• Participated in producing integrated summaries of safety and efficacy.
• Extensively used PROC FREQ, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC CONTENTS, PROC COMPARE and PROC UNIVARIATE.
• Collaborated with statisticians and medical researchers in preparing formal reports.
• Generated SAS Customized reports using the DATA NULL and PROC REPORT techniques.