SUMMARY

• Over 7 years of experience as a clinical SAS programmer in clinical research and statistical analysis with strong emphasis on design, implementation and development of various projects in Pharmaceutical companies and Clinical Research Organizations (CROs)
• Strong knowledge of clinical trial data and good experience in designing, developing and analyzing the data, debugging the errors, reviewing the SAS code
• Experience in creating and validating SDTM and ADaM datasets and in producing TLG’s and summaries based on company’s and the client’s requirements
• Extensive experience in generating reports and creating summaries according to the specifications of Statistical Analysis Plan (SAP) and Standard Operating Procedures (SOP)
• Proficient in creating tables using Proc Report, Proc means, producing and customizing Graphs using Proc Gplot
• Part of a team for FDA e - submissions. Created Deliverables like annotated CRF and .XPT files
• Generated various SAS reports according to the 21 CFR-Part11.
• Created PDF, RTF, HTML files using SAS/ODS
• Experience in producing safety and efficacy reports-Integrated Summaries of Safety and efficacy
• Experience working with different coding dictionaries like MedDRA and WHODrug
• Designed and developed datasets as per the CDISC standards
• Good in handling multiple projects at a time and large databases to perform complex data modifications
• Excellent Collaboration and Communication skills (written and verbal)
• Good technical and Analytical Skills and ability to work in a team as well as independently

TECHNICAL SKILLS

SAS Tools: SAS/BASE, SAS Advanced

Operating Systems: Windows XP, UNIX

Programming languages: C, C++, SAS

PROFESSIONAL EXPERIENCE

Confidential, NC

SAS Programmer

Responsibilities:

• Worked on different projects for different clients
• Worked in conjunction with Statisticians, Data Management and Analysis programmers.
• Involved in developing SDTM from the raw datasets and derived ADaM datasets, Summary datasets and generating TLG’s
• Worked both as a primary and a QC programmer. Involved in validating datasets and tables
• Created Macros for further reference in different studies, modified the existing macros and used company macros for data analysis.
• Created Summary tables, Categorical Tables and data listings and figures for Clinical Study Reports in compliance with 21 CFR part 11,FDA regulations and standard procedures
• Performed Data Validation according to SAP
• Generated ISS reports for e-submissions
• Worked on cleaning and debugging the data
• Documented the programs and provided development support for the statistical analysis of the clinical data
• Worked on both Randomized, Blinded and Unblended trials in different studies
• Generated KM Plots using the censor variables and regression using the model and estimates provided by the statistician.
• Converted datasets to SAS transport format.

Environment: SAS V9.1.3 (Widows environment) SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL, SAS/GRAPH, Windows XP, Microsoft Office 2003, Microsoft ExcelTherapeutic Areas: Oncology and Neurology

Confidential, Morrisville, NC

Programmer Analyst

Responsibilities:

• Worked in collaboration with project managers, data managers and other statisticians to develop tables and define analysis populations
• Responsible for cleaning, developing and modifying the disorganized and complex data
• Performed statistical analysis for the clinical trials data using SAS programming techniques
• Performed clinical data edit checks and involved in extraction and data migration from flat files, SAS datasets
• Tested SAS programs on the mock data to implement the statistical procedures in a way to perform complete and clean analysis
• Created SDTM and ADaM datasets and TLG’s for the regulatory submissions of CRT’s and summaries
• Developed graphs using SAS/ODS graphics (SAS 9.1)
• Performed data validation using Proc compare and proc freq
• Followed 21 CFR-part 11 and other industry regulations.

Environment: SAS V9.1 (Widows environment) SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL, SAS/GRAPH, Windows XP, Microsoft Office 2003/2007, Microsoft Excel

Confidential, Princeton, NJ

SAS Programmer

Responsibilities:

• Developed new datasets and modified the existing ones to create specific datasets as a source for generating reports in Phase I,II clinical trials
• Extracted data and generated ad-hoc reports
• Created TLG’s using Proc Report, Proc Means, Proc Sql, Proc Freq, data Null as per the statistician’s requirements referring to SAP
• Performed Preliminary Data validation on the clinical trial data
• Used Proc Freq, Proc Univariate and Proc Compare to identify outliers
• Also designed and developed SDTM datasets to simplify the production of CRT’s(Case Report Tabulations) and ADaM datasets for creating statistical summaries and analysis
• Developed Macros for the reusability of the SAS code wherever required
• Responsible for handling and verifying the data to conduct statistical analyses and preparing trial reports
• Provided efficient support to all the team members.
• Imported/Converted randomization data files from Excel, .CSV data files into SAS data sets for analysis.
• Performed SAS Edit Checks on the raw SAS data sets.

Environment: SAS V8, SAS/MACROS, SAS procedures, Microsoft office 2003, Excel, Windows XP

Confidential

Programmer Analyst

Responsibilities:

• Responsible for data collection, management and manipulation of clinical database.
• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Prepared clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Used SAS for pre-processing data, SQL queries, data analysis, generating reports, graphics, and statistical analyses.
• Maintained clinical trial data base, accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Retrieved data from Oracle using SQL within SAS to be analyzed and exported to Excel for further analysis.
• Created and implemented statistical analysis plans and specification documents
• Supported the research staff for technical and programming help. Worked with Bio statistician to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM, t test.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.

Environment: SAS 9, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, Oracle 8 PL/SQL, ANOVA, Windows NT and UNIX.

Confidential

SAS Programmer

Responsibilities:

• Provided statistical and analytical support to Consumer Economics, Planned and performed load research studies and analysis.
• Prepared statistical summaries and reports on customer load usage surveys for use in regulatory hearings.
• Developed SAS macros for data cleaning and Reporting and to support routing processing.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Also identified problems with the data, if there were any, and also produced derived data sets, tables, listings and figures, which analyzed the data.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.

Environment: SAS, Oracle, Developer/2000, Reports 3.0