SUMMARY

• SAS certified base programmer with 7.5 years of programming experience in pharmaceutical industry.
• Good knowledge and understanding of drug development process from protocol to FDA submission.
• Extensive experience in Clinical Data Analysis for Phase I - IV Protocols and strong experience in CDISC SDTM, ADAM standards.
• Worked with Bio-statisticians and clinical data managers to provide SAS programming in extracting and analyzing the data and generated reports, tables, listings and graphs.
• Experience with SAS/STAT procedures such as Proc Corr, Reg, Glm, Anova, Univariate and Mixed.
• Expertise in using various SAS report generating procedures like PROC REPORT, PROC SQL, PROC FREQ, PROC MEANS, PROC TABULATE, PROC TRANSPOSE, PROC PRINT.
• Thorough experience in analysis of Clinical Trial data and in preparation of SAS datasets/views, Tables, Listings, Graphs, Reports and Summaries as per requests of users, according to Protocols and Statistical Analysis Plans.
• Extensive knowledge in creating macros for developing controlled terminology, variable metadata, value level metadata from the SDTM and ADaM datasets.
• Excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Ability to work effectively with multiple protocols as an individual and also as a part of the team.
• Validated and performed Edit checks on reports and data generated by other members.
• Experience in developing Validation Plans, Validation Reports and Verification logs.

TECHNICAL SKILLS

Operating Systems: MS DOS, WINDOWS 95/98/2000/NT/XP/VISTA/7,UNIX

Languages: SQL,HTML

SAS Skills: SAS/BASE, SAS/MACRO, SAS Enterprise Guide, SAS/SQL, SAS/STAT, SAS/ACCESS, SAS/ETL, SAS/AF, SAS/GRAPH AND SAS/ODS.

Documentation: MS-WORD, MS-EXCEL,MS-Access,MS- Power Point

PROFESSIONAL EXPERIENCE

Confidential, NJ

Sr.SAS Programmer

Responsibilities:

• Responsible for SAS programming for data analysis, data validation, statistical analysis, documentation, and generation of reports, tables, listings, graphs.
• Used SAS and SAS tools for the Clinical trials data and performed the sorting and merging techniques to prepare and validate data for the input data sets, to get the required output and then written the code using SAS tools.
• Created SDTM and ADAM data sets using CDISC standards.
• Experienced in oncology trials.
• Developed SAS programs and macros to perform Edit checks and post data entry verifications.
• Involved in validation of SDTM data sets by using OPENCDISC validator.
• Performed file conversions, data validation, data import and transfers independently.
• Developed systematic documentation of methods and results, including programming.
• Assisted in developing analysis plan, summarizing and synthesizing results into reports and publications.
• Used PROC LIFE TEST to generate Kaplan Meier survival curves and Kaplan Meier initial treatment curve.
• In-depth knowledge of statistical analysis techniques for clinical studies, and excellent experience in analyzing clinical study data.
• Used different macros as per protocol need and wrote some summary report Macros for specific needs.
• Created some PK listing and reports for one of the pediatric study.
• Experienced in Integrating Data from multiple studies and sources.
• Experienced in importing and exporting Data from SAS.

Confidential, Durham, NC

Sr.SAS Programmer

Responsibilities:

• Performed the validations of dataset, and TLGs as per the program requirement and specifications.
• Worked with Statisticians on data integration for efficacy and safety tables.
• Created SDTM data sets and created analysis data sets in ADaM format.
• Involved in preparing specifications and programming of mapping Raw Datasets to CDISC SDTM standards.
• Integrated data from multiple studies for ISS and ISE.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC MEANS, FREQUENCY, and UNIVARIATE.
• Created and extracted Oracle tables from SAS and within Oracle by using SAS/ACCESS and SAS/SQL.
• Created SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards.
• Conducted and generated the Regression, Correlation studies and Analysis of Variance (ANOVA).
• Interacted with Clinical, Regulatory, and Data Management staff to coordinate collection and reporting of clinical trial results.
• Collaborated with managers, statistician, and medical writer back and forth for abstract, Manuscript and posters.

Confidential, Elkridge, MD

Sr. SAS Programmer

Responsibilities:

• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis of safety and efficacy data.
• Did validation and quality control check of the displays and datasets according to the different QC levels.
• Worked on different kinds of data, including demography, adverse event, vitals signs, ECG, concomitant medications, pharmacokinetic concentration and laboratory data.
• Used existing Macros to produce datasets and displays and produced macros for validation.
• Used PROC REPORT to produce reports for the purpose of validation.
• Did checking of the data received from the data management and notified them of any issues found.
• Multitasked by working on a number of studies at the same time.
• Used SAS/STAT like PROC MEANS, PROC UNIVARIATE, PROC FREQ and PROC REG for analysis.
• Worked on Ad-hoc requests from studies in other therapeutic areas and provided programming support to the projects.

Confidential, Cary, NC

SAS Programmer

Responsibilities:

• Performed relevant statistical analysis of Clinical Trials.
• Provided SAS programming and statistical support to Clinical studies.
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Responsible for developing new SAS programs and modifying existing SAS programs.
• Converted information from MS-Word documents, MS-Excel, Oracle tables into SAS data sets.
• Responsible for developing programs with SQL, for extracting data from ORACLE tables.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL.
• Developed SAS macros for data cleaning and Reporting and created SAS Graphs

Confidential

SAS Programmer

Responsibilities:

• Created Analysis Datasets, Tables, Listings and Graphs as primary programmer and validated as a secondary programmer.
• Developed Programs to generate Exceptional Reports, Sponsor Listings to identify data issues.
• Involved in day to day activities related to SAS Programming.
• Worked closely with statisticians to resolve data issues with the clinical trial data.
• Communicated with Statisticians about various TLG specifications related issues.
• Converted SAS data sets to various file formats such as HTML, PDF, RTF, Excel etc. using SAS/ODS and PROC EXPORT.
• Involved in CRF-Annotation with respect to various database designs.
• Carry out all activities according to SOPs.
• Served as a resource for technical solutions for SAS & IT related problems.
• Built complete format libraries for various studies.
• Prepared yearly and quarterly IND annual reports for US and European Health Authorities.