SUMMARY

• 7+ Years of experience in developing and implementing various applications in Healthcare, Pharmaceutical and Clinical Industries.
• Certified in SAS/BASE 9.
• Proficiency in all phases (I - IV) of clinical trials, and electronic submissions.
• Experience in therapeutic areas Central Nervous System, Oncology, Hematology, Virology, and Epidemiology.
• Extensive experience in preparation of ad-hoc reports, tables, listings, graphs and healthcare reports.
• Profound Knowledge and strong experience in Base SAS, SAS/MACRO, and SAS/ODS, SAS/GRAPH, SAS/SQL.
• Strong experience in SAS/STAT, SAS/Connect.
• Experience in developing and implementing SAS procedures, macros, and applications for data cleaning, reporting, and documentation.
• Good experience in storing and managing data in SAS files, merging SAS Data sets.
• Experience with reports employing various SAS procedures, like null, ODS, Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort and Proc SQL.
• Experience in using SAS to import and export to another data file formats, including delimited files, Spreadsheets, Microsoft Excel and Oracle databases.
• Working knowledge in the CDISC and MedDRA regulated environment
• Good understanding of drug development process - conducting clinical trials, collection (paper CRF, eCRF (EDC)), analyses, presentation of data and CDMS
• Concepts like Database design documentation, Data validation including Edit checks,
• Discrepancy handling and data handover to Statistics department for Analysis and reporting.
• Excellent understanding of Bio-statistical workflow: Starting from Raw Datasets/DM Datasets to creation of submission package i.e. CRT packages.
• Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines.
• Documented SOP, work instruction, processes and standards as per FDA regulations.
• Highly self-motivated and goal-oriented professional with rational problem solving and sound decision making capabilities.
• Very good team player with excellent communication skills. Ability to work independently with least supervision.

TECHNICAL SKILLS

SAS Skills: SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/SHARE, SAS/IntrNet, SAS/ETL, SAS/STAT and SAS/Connect

Languages: SAS, and SQL

Database: SQL, Oracle, DB2 and MS Access

Application/OS: Windows 2000/ XP, UNIX

PROFESSIONAL EXPERIENCE

Confidential, Canton, MI

Sr.SAS Programmer Analyst

Responsibilities:

• According to the requirements, created metadata for the analysis datasets.
• Produced analysis ready datasets using standard set of macro tools and non-standard tools according to the CDISC standards.
• Developed SDTM data mapping and created SDTM datasets per CDISC standards.
• Designed and develop Statistical analysis data set ADaM in CDISC standards.
• Assist the Manager of Clinical programming in overseeing the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverable are created per agreed timelines and to high quality standards. Ensure SAS programs adhere to SOPs, guidelines, and specifications.
• Ensure SAS program output matches the requirements of the Statistical Analysis Plan. Consult with managerial, statistical, data management, DIS, and medical writing personnel to clarify program intent, identify problems, and suggest changes.
• Design and/or review database structure. Create derived-analysis datasets. Execute analyses specified in the Statistical Analysis Plan (SAP) or Report and Analysis Plan (RAP) under the guidance of the project statistician.
• Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email. Worked on different domains like DM(demographic), AE(Adverse event), SC(subject characteristic), VS (vital sign), EG (Electro Cardiogram), LB(Laboratory) etc
• Performed different types of statistics in generating those kinds of reports like PROC FREQ, PROC MEANS, PROC GLM, PROC MIXED Etc. Extensively used PROC REPORT, PROC TABULATE and ODS output to generate report as per the desire format.
• Successfully moved data through multiple platforms by importing and exporting from and to external data sources like Excel, Access, Delimited files, PC files and Spreadsheets using PROC IMPORT, PROC SQL and also Dynamic Data Exchange (DDE).
• Used SAS/GRAPH to present data analysis-using PROC GCHART, GPLOT etc. Extensive used SAS/ACCESS, SAS/CONNECT to connect to various databases (SYBASE, DB2, SQL SERVER) such as development and production database (DB2 on UNIX).
• Extracted data from IBM mainframe and create pipes delimited flat files and reports as per requirements. Analyzes data using various statistical procedures like PROC SUMMARY, PROC MEANS, PROC FREQ, PROC LOGISTIC, PROC REG, and PROC ANOVA.
• Assisted in investigating and applying new SAS programming methods and techniques to enhance current systems by using various SAS macros and standard programming procedures.
• Created new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.
• Modified macros for report generation using SAS Macros as per the requirements. Generated highly customized reports using SAS/MACRO facility, PROC REPORT, PROC TABULATE and PROC SQL. Worked on extending SAS Enterprise Guide and Enterprise miner capabilities by developing customized add in programs. Generated high quality reports in the form of listing, HTML, RTF and PDF formats using SAS ODS.

Environment: MS Excel, MS Access, HTML, XML, Java, DB2, MS Project, Oracle9i, SYBASE, SAS/BASE, UNIX, WINDOWS 2000, Enterprise Guide, ERWIN, SAS OLAP Cube Studio, SAS Information Map Studio, SAS Web Reporting Studio, SAS Enterprise Miner, SAS Enterprise

Confidential

SAS Programmer

Responsibilities:

• Developed SAS programs to generate Provider Profiles for the Eligibility, Medical Claims, Pharmacy Claims, and Clinical Quality Reports.
• Worked with Statisticians in analyzing the Health Care Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Worked in multidisciplinary teams closely with statisticians, medical writers, and data managers.
• Assisted fellow programmers in validation, edit checks, and data review listings.
• Utilized SAS/ACCESS to gather data from RDBMS such as ORACLE, and data sources extracted into the ORACLE tables were later extracted into the ODS.
• Applied SAS/STAT to present results in BAR charts, LINE plots, and SCATTER plots.
• Extensively used various procedures such as PROC (Such as PRINT, SQL, UNIVARIATE, MEANS, FREQ, TABULATE, REPORT, SUMMARY, GPLOT, GLM and IMPORT.)
• Developed efficient, well-documented and readily comprehensible SAS code using SAS/ Base and SAS/ Macro facility.
• Performed various adhoc analyses as per user’s guidelines and requests.
• Document SOP, work instruction, processes and standards as per regulations.
• Utilized BASE SAS, SAS STAT and SAS MACROS for writing, editing, validating, and debugging code.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/GRAPH, MS Access, UNIX, Windows, Oracle, Excel.

Confidential, Dallas, TX

SAS Clinical Programmer

Responsibilities:

• Produced analysis datasets and generated tables, listings, and graphs using SAS.
• Wrote SAS listings and tables in PDF, RTF, CGM formats using SAS ODS.
• Developed standard report for safety data including laboratory and adverse event summaries for NDA (New Drug Application) updates using Proc REPORT and DATA NULL.
• Developed and maintained routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions.
• Converted ORACLE data tables into SAS data files using SAS SQL Pass through Facility.
• Table programming for Summary of Clinical Safety for FDA submission.
• Used statistical procedures such as Proc Gplot, and Proc Gchart for creating Graphs.
• Involved in calculating and analyzing the p-values and CI limit for drug analysis
• Performed and documented quality reviews of SAS programs and data generated by other SAS programmers.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/GRAPH, UNIX, Windows.

Confidential

SAS Programmer Clinical Trials

Responsibilities:

• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed safety and efficacy data from Phase I, II and III clinical trials.
• Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.
• Performed reporting, validation and documentation in compliance with FDA
• Merging and sorting of data collected at different time intervals.
• Performed statistical data analysis, generated ad-hoc reports, tables, listings and graphs using tools such as SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL and SAS/STAT.
• Performed documentation on all programs, files and variables for accurate historical records and for future reference.
• Different array elements are created at different time intervals using an ARRAY statement and compared using a nested DO loop to establish the potency/efficacy of two drugs when compared to Controlled Clinical Trials
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time.
• Produced quality customized reports by using PROC TABULATE, PROC REPORT, and PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ and PROC UNIVARIATE.
• Performed testing, documentation, review, and verification of all programs according to SOPs.
• Performed sorting and merging techniques on the input data sets for Data Preparation.
• Cleaned, transformed, analyzed, and presented clinical data using PROC SQL.

Environment: SAS Base 8.2, SAS/Graph, SAS/ Macro, SAS/Stat, Windows NT, UNIX

Confidential 

SAS Programmer / Analyst

Responsibilities:

• Reviewed and evaluated clinical research related programs,
• Programming of data listings using SAS.
• Programming of data validation tools using SAS.
• Worked in Phase I and II of Clinical Trials.
• Verified the accuracy and integrity of clinical data by performing validation checks and investigate data related errors, outliers, and missing values. Developed SAS macros for data cleaning and reporting.
• Involved in preparation, developing data, analyzing, coding, report generation and testing programs according to client’s requirements.
• Extracted raw data from the warehouse and created SAS data sets that are required for the project analysis using SAS/ACCESS and SAS/CONNECT.
• Used existing macros as well as developed new SAS macros to create tables, graphs and listing for inclusion in clinical study reports and regulatory submissions.
• Involved in preparing analysis plan, data analysis and statistical report writing presentations to DA.
• Created complex and reusable macros.
• Testing and debugging macros.
• Used frequently PROC TABULATE, PROC REPORT, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ, PROC ANOVA and PROC REG.
• Strong knowledge in t-test, F-test and Chi-square (c2) test.
• Used PROC PRINTTO and ODS objects to get customized reports.
• Used PROC ANOVA, PROC MEANS and other analysis procedures in generating real time reports.
• Understood importance of validation (verification/documentation) process in compliance with regulations and policies.

Environment: SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/ODS, SAS/Access, Oracle, MS-Access and Windows NT.