PROFESSIONAL SUMMARY:

• Statistical Programmer/ Analyst with around 9 years of experience with emphasis in statistical analysis of Phase I - IV Clinical trials data.
• Extensive experience in using various SAS tools like SAS/BASE, SAS/ MACROS, SAS/STAT, SAS/GRAPH, SAS/ ODS, SAS/ACCESS, SAS/ CONNECT, and SAS/ SQL.
• Extensive experience in Data Mining, Data Management, Analysis and Reporting.
• Excellent work experience in generating adhoc reports, tables, listings, and graphs according to Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Experience in modifying existing SAS programs and created new programs using SAS macros to improve ease and speed of modifications as well as consistent results.
• Developed Integrated Analysis of Safety & Efficacy - ISS & ISE and worked on INDs & NDAs submissions.
• Excellent knowledge of SAS procedures like Proc Format, Proc Report, Proc Means, Proc Summary, Proc Freq, Proc Univariate, Proc SQL, Proc Import, Proc Tabulate, Proc Mixed and the NULL data step.
• Experience in implementing SAS procedures, macros, and applications for data cleaning, reporting, and documentation. Developed SAS Macros for generic coding and reusable modules.
• Experience in providing software solutions using windows SAS 9.0/9.2, MS-Access/Excel.
• Created summary reports for ISS and ISE analyses of clinical trial study for FDA regulatory submissions.
• Handled multiple protocols simultaneously and worked on various studies both as a production and validation programmer.
• Ability to take ownership of entire study deliverables and utilize available time and resources to meet deliverables of the highest quality outputs.
• Developed standard macros and also used existing macros wherever possible by defining the macro parameters and different debugging options like MPRINT, MLOGIC and SYMBOLGEN.
• Handled multiple protocols simultaneously and worked on various studies both as a production and validation programmer.
• Experience in Producing RTF, HTML and PDF formatted files usingSAS/ODS.
• Familiar with various statistical theories and applications such as ANOVA specifically designed for ‘analysis of variance’ on balanced data, predictive solution models such as General Linear Regression Models & Regression Analysis.
• Good understanding ofClinicalTrial Protocol and CRF annotation and participated in review of Protocols, CRF's and Statistical Analysis Plan (SAP).
• Worked in conjunction with CROs to perform Clinical Data Analysis for Phase I - III Protocols with strong experience in mapping the raw data into SDTM/CDISC standards.
• Creating ADaM analysis data sets from SDTM data sets
• Experience with 21 CFR Part 11 compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) and Coding Dictionaries such as MedDRA.
• Extensive experience in the Pharmaceutical/ CRO domain.
• Possess strong analytical, effective communication, interpersonal, organizational and execution skills.

TECHNICAL SKILLS:

SAS Programming Tools: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/ODS, SAS/ACCESS, SAS/STAT, SAS/ETS and SAS/GRAPH, UNIX SAS.

Operating Systems: Windows2000/XP, UNIX.

Office Tools: MS-Office Desktop tools.

PROFESSIONAL EXPERIENCE:

Confidential, Home based, NC

Clinical SAS Programmer

Responsibilities:

• Developed SAS programs to create analysis datasets such as ADSL, ADAE, ADLB and ADCM etc., as per ADaM in CDISC standards.
• Involved in leading the study and the development of TLG’s and ADaM analysis datasets according to specifications in the SAP (Statistical Analysis Plan).
• Mentoring new and junior programmers and serving as a point of contact for process/system related questions.
• Developed mapping Macros for SDTM and Adam data sets. Worked on Ad-hoc requests for various studies in different therapeutic areas and provided programming support to the projects.
• Used study specific Macros in therapeutic areas like Oncology and CNS which were provided by companies to create summary tables for safety and intent to treatment (ITT) populations
• Responsible for providing Validation, including testing and documentation, in accordance with company SOPs.
• Worked on interim analysis for Phase II study and generated safety tables related to lab, study completion, study discontinuation, concomitant medication and demographics.
• Developed and Validated Reports and Listings of Demographic, Drug Exposure, Medical History Different Groups of Laboratory Data, Vitals, and Physical Examination and Concomitant Medications.
• Generated safety listing reports using specialized macros and basic SAS procedures.
• Identified data issues and reported the same to the statisticians and lead programmer.
• Modified programs and reports to meet the requirements and coordinated with the statistician to meet the required standards.
• Meticulously analyzed and validated data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ.
• Developed SAS macros to create Tables, and Listings using PROC REPORT for Clinical Study Reports.
• Developed programs to create SDTM domains, reviewed programs using PROC COMPARE for quality check of the SDTM domains.
• Provided support for biostatisticians, medical writers by creating TLGs (Tables, listings and graphs) for annual reports, monthly safety reports and also for the preparation of CSR (clinical study report). Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.

Confidential, Wayne, PA

SAS Programmer

Responsibilities:

• Generated safety tables and listings related to adverse events, labs, study completion, study discontinuation, concomitant medication and demographics.
• Contributed to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
• Contributed in development and implementation of programming standards and conventions.
• Interacted with clients and participate in meetings with regards to update project status, issues and timelines.
• Generated Annual Safety Reports, Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR) and Monthly Safety Reports by pooling data across multiple protocols.
• Checking the numbers across various tables and listings to ensure consistency across reports.
• Compared multiple database structures and re-formatted datasets to ensure consistency of variable names and formats across multiple protocols.
• Performed development and validation/QC programming of analysis datasets, tables, listings, and figures, for multiple clinical trials.
• Created detailed specification documents for dataset, table and listing programs in word and excel format.
• Performed edit checks to eliminate duplicate records and other data issues across several protocols for ISS analysis.
• Modify existing datasets to changing specifications, addition of new variables and quality control analysis datasets by double programming.
• Cross-validated SAS programs created by other programmers of ADaM, SDTM, Tables and Listings.
• Worked closely with team lead and Statistician and prepared adhoc reports for analysis.
• Participated in data cleaning process by reporting various errors in data and related issues to the data management team.
• Performed program documentation on all programs, files and variables for future . Programmed all study-specific edit checks and review listings.
• Attended project team meetings, interacted with Bio - Statisticians, Data Managers, and Clinical Research managers.

Confidential, Bridgewater, NJ

SAS Programmer

Responsibilities:

• As a SAS programmer and collaborate with statistician in analyzing initial data sets and generated tables, listings and figures (TLFs) for clinical trials.
• Developed SAS programs using parallel programming for QC and validation.
• Developed standard report for safety and efficacy data including laboratory and adverse event summaries for NDA (New Drug Application).
• Interacted with clients and participate in weekly team meetings with regards to updating programming issues and timelines.
• Ensured report consistency by matching the numbers across various tables and listings.
• Participated in data cleaning process by reporting various error data related issues to the data management team frequently.
• Responsible for preparing various tables, listings using various DATA STEPS and SAS Procedure.
• Use SAS/Base, SAS macros and SAS/SQL to perform merging, sub-setting, coding, and decoding, transforming, analyze data, and create listings, tables for clinical trials, explanatory analysis.
• Conduct statistical analyses, including descriptive statistical summary, T-test, ANOVA, PROC GLM, Survival Analysis by using PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ etc.
• Import and/or export datasets from and/or to different sources like a spreadsheet of Excel, part of a spreadsheet of Excel, CSV file, flat file, Access, and data file with delimiters, SAS transport files etc.
• Developed SAS programs to perform edit checks on clinical data received from CRO's and internal data warehouse for data integrity.
• Cross-validated SAS programs created by other programmers of Tables and Listings.
• Maintained program documentation for historical events and for future .

Confidential, Gaithersburg, MD

SAS programmer

Responsibilities:

• Performed data mapping from CDISC data sets to STDM and data mapping from STDM to Adam standards.
• Generated tables and listings for Adverse Events, Vital signs,clinicallaboratory evaluations, disposition of subjects, concomitant medications and protocol violations.
• Generated summary tables, graphs and data listings for interim and final analysis onclinicaldata. Worked as a validationprogrammerat protocol level for setup programs.
• Generated output in various formatted files such as Excel sheets, RTF and PDF usingSAS/ODS.
• Experience in creating user friendly macros and replacing the code with macros to reduce code redundancy.
• Worked with Bio statistician to analyze the results obtained from various statistical procedures like proc ANOVA, GLM and T test.
• Resolved requests issued from the study teams on SDTM domains.
• Enhanced existingSASprograms and created new programs usingSASMacro variables to improve ease and speed of modification as well as consistency of results.
• Produced TLG's for Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).Performed QC, Data validation and edit checks using various procedures andSASmacro facility.
• Generated Ad hoc Listings to Data Management in the form of .rtf files, as per the request.
• Created datasets, reports, and summaries using Proc SUMMARY, Proc REPORT, Proc UNIVARIATE and Proc TABULATE.
• Assisted statisticians in generating frequency distributions and to present the results in histograms, box-plots, pie-chart and scatter-plots using the graphical procedures.