SUMMARY

• SAS certified Programmer with over 7 years of industry experience in using SAS for data management and reporting in the CRO’s and Pharmaceutical fields.
• Strong working knowledge on all 4 phases (Phase I, II, III, IV) of clinical trials and their designs including open - labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Enterprise Guide, SAS/Stat & SAS/Graph and has good knowledge of GCP, GPP and US FDA & CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well
• Good understanding of regulatory requirements, NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). This includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary (ISS & ISE) for FDA submission
• Creation of specifications files for creating analysis datasets, TLGs / TLFs and Ad-hoc reports
• Preparing FDA E-submission ready reporting documentation including creating DDT’s, Transport files (XPORT format files)
• Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs
• Experience in producing external files and reports employing various SAS statements and procedures, such as null, ODS, Proc Print, Proc Report, Proc Tabulate in Clinical Trials
• Deadline Prioritization, Management Skills, good team lead and the attitude to constantly strive to mould to the dynamic requirements of the competitive workplace
• Experience in implementing CDISC SDTM for intervention, event and findings domain models and ADaM standards, knowledge of SDTM terminologies
• Developed SDTM data mapping and create SDTM datasets per CDISC standard for FDA
• Worked extensively on various SDTM domains such as AE, CM, LB, DM, SE, EG, EX, IE etc and their SUPPQUAL datasets
• Performed Data Analysis validation and created the programs to as per the specifications required to run in the SAS drug development (SDD)
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results

TECHNICAL SKILLS

Operating Systems: Windows, UNIX.

Databases: SQL, Oracle, MS SQL Server, MS ACCESS.

SAS Skills: Base SAS 9.2, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/Graph, SAS/ODS

Other Skills: WORD, EXCEL, POWER POINT.

PROFESSIONAL EXPERIENCE

Confidential, Mounds View, MN

SAS Programmer Analyst

Responsibilities:

• Created CDISC SDTM domain datasets from existing clinical trial data using SDTM Implementation guides - Human Trails and Medical Devices(v3.1.2 and v1.0).
• Developed and documented programs to create analysis datasets summarizing key clinical trial data according to specifications provided by Biostatistician using the extracted raw datasets as the source.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools - SAS/Base, SAS/Macros and SAS/SQL.
• Documented information related to SAS programs, data files and other issues.
• Created project specific Macros, Template and Format catalogue.
• Debugged and validated programs for logical/ syntax errors in accordance to company guidelines.
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time and created tables, listing and graphical reports.
• Generated output files in text format, HTML & PDF format using SAS ODS
• Created SAStransport (.xpt) files and converted the Transport files into SASData Sets.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Created tables, listings and figures for Progress, Interim and Annual reports.
• Worked with raw data to create mapped and analysisdata sets.
• Validated mappeddata setsand tables for high priority work.
• Supportedstudy team with adhoc requests and study specific listing in post approval studies.
• Programmed studymanagementreports to help the study team. Eg:Visit compliance, Device disposition etc.
• Experienced in doing user acceptance testing(UAT) with study data for data management team.
• Established and maintained a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Database personnel.
• Good working knowledge of 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.

Environment: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/ACCESS,SAS/STAT, MS Office, WINDOWS.

Confidential, Overland Park, KS

SAS Programmer

Responsibilities:

• Created, derived and pooled datasets, listings and summary tables for Phase-I and Phase-II of Clinical Trials.
• Verified the accuracy and integrity of Clinical data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.
• Developed SDTM data mapping and create SDTM datasets per CDISC standard for FDA.
• Created Analysis Datasets from SDTM datasets as per CDISC standards for Analysis purpose.
• Developed and Executed edit check programs according to specifications provided by clinical data management operations for purposes of database verification.
• Used SAS SQL Pass through facility and Libname facility to import and create datasets from Oracle Clinical database .
• Developed and executed Proc SQL queries for merging, concatenating, and updating large volumes of data.
• Used Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc) and SAS/STAT procedures (REG, GLM, ANOVA, UNIVARIATE etc.) for summarization, Cross-Tabulations and statistical analysis purposes. The generated reports were reviewed and then sent to the FDA.
• Developed standard reports for safety data including laboratory and adverse events summaries for IND (Investigational New Drug).
• Developed Macros for various instances for automating listings and graphing of Clinical data for analysis.
• Developed statistical reports by using Proc Report, Data null and SAS Macro.
• Executed report programs and imported the results into Excel for data analysis.
• Created Adhoc reports using the SAS procedures and created reports using ODS statements and Proc Template to generate different output formats like html, pdf and excel to view them in the web browser.
• Collaborated with Clinical Data Management to annotate CRFs with standardized variables and formats using Proc Datasets, Proc Formats.
• Performed data extraction from various repositories and pre-process data when applicable.
• Understood importance of validation/verification process and compliance with regulations and policies by creating Constraints.

Confidential, Deerfield, IL

SAS Programmer/Analyst

Responsibilities:

• Involved in programming clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets .
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Extracted, validated and generated SAS data sets from Oracle, applied ‘SQL Pass through Facility’.
• Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.
• Extensive interaction with the functional users to understand the requirements on statistical methods and measures.
• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase, and Clinical Trials.
• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Maintained appropriate study application documentation.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures (e.g., Proc Means, Proc Freq, Proc Report).
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/functions/procedure for data manipulation.
• Used the SAS Macro facility to produce weekly and monthly reports..
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Produced Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA and other regulatory compliance.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA .

Environment: SAS/ Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, and MS-Excel

Confidential, Knoxville, TN

SAS Programmer

Responsibilities:

• Developed and maintained programs in SAS using SAS tools for Windows and Unix in a user support environment.
• Explained the purpose and functions of complicated SAS programs to non-statistical personnel, and was responsible for ensuring the validity and accuracy of data analysis.
• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
• 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.
• Database Creation and Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Created SAS Customized Reports using the Data Null technique for FDA evaluations.
• Performed Data analysis, generated reports, listings and graphs using SAS Tools - SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Data transmission and integrity check of the existing and in-house Clinical Trial Systems.
• Produced quality customized reports by using PROC TABULATE, REPORT, SUMMARY and also provided descriptive statistics using PROC Means, Frequency, Univariate.
• Involved in writing of clinical trial reports (phase I-III), analyzing, and presenting trial results.
• Created and extracted Oracle tables from SAS and within Oracle by using PL/SQL.
• Created survival graphs in MS-Excel by transporting SAS data sets into Excel spreadsheets.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Used the SAS Macro facility to produce weekly and monthly reports

Environment: BASE SAS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STATSAS/Enterprise Guide, MS Access, Excel, Oracle, Windows XP / 2000 and UNIX

Confidential, CA 

Clinical SAS Programmer

Responsibilities:

• Created database for Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS) for phase III studies and presented same data in SAS Graph using ANNOTATE for presentations and quick look at interim analyses
• Used SAS macros to perform data validations and supported other programmers with data deliveries for regulatory submissions
• Provided programming support Phase III study to conduct statistical analysis for confirming the safe dosing frequency, safety and efficacy
• Produced data listings, summary tables and graphics for interim and final analysis and publications
• Participated in requirement reviews and maintained existing SAS code and validated code with requirement specifications
• Converted SAS listings and tables into PDF, RTF, HTML formats to meet specifications by using SAS ODS
• Used CDISC models for submission of clinical data in electronic format to the FDA.
• Generated analysis datasets and transport files for FDA submission by using XPORT engine and PROC COPY

Environment: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/CONNECT, SAS/STAT, PL/SQL, MS Office, WINDOWS