SUMMARY:

• SAS Institute Certified BASE SAS® Programmer with over five years of experience in working with SAS and SAS tools with emphasis on analysis, design, development, testing and implementation of various projects for Pharmaceutical and Biotechnology Industries.
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ CONNECT, SAS-SQL, SAS/ASSIST, SAS ODS in windows and Unix environments.
• Thorough knowledge in SAS programming, merging SAS Data set, Macro Facility, Preparing data, Producing reports, SAS formats, SAS functions, SAS statements, SAS Informats and involved in all four phases of clinical trials.
• Knowledge of Advanced Data Editing Procedures for Data corrections and Data validation using PL/SQL.
• Experience in working on Phase I, Phase II, Phase III and Phase IV (Post-market study) .
• 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.
• Working Knowledge of statistical procedures: PROC FREQ, PROC MEANS, PROC SUMMARY, PROC REPORT, PROC TABULATE, and PROC UNIVARIATE.
• Knowledge of PROC TTEST, PROCNPAR1WAY, PROC ANOVA, PROC GLM, PROC MIXED.
• Working knowledge in the CDISC and MeDRA Regulated Environment.
• Knowledge of CRT Dataset Creation from clinical trial data.
• Knowledge of CRF-Annotation with respect to various database designs.
• Worked with senior Bio-statisticians and clinical data managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs.
• Experienced in Validation and Integration of data from disparate sources such as Electronic Data Capture Systems, in-house Clinical Data Management Systems, labs and Contract Research Organizations for help in better analyzing the data.
• Knowledge of new drug & device release process from IND submission to FDA approval to post market study, which includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE) for FDA submission .
• Involved in the process of generating TLG's for IntegratedSummaries of Efficacy (ISE) and Safety (ISS) for FDA submission. Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.
• Expertise in analyzing and coordinating clinical data, generating detail and summary reports, and data validation.
• Experience in developing SAS Procedures, Macros, and application for data cleaning, reporting and involved in preparing documentation.
• Familiar with FDA computer systems validation guidelines and electronic records/signature regulations, 21 CFR Part 11.
• Highly conceptual innovative problem solver with excellentorganizational and communication skills.

CERTIFICATIONS:

SAS Certified Base Programmer.

TECHNICAL SKILLS:

Statistical Software

SAS6/8, SAS BASE, SAS/GRAPH, SAS/MACROS

Languages

SAS v6/v8/v9, C, C++, Xml, Html, SQL, Pl/Sql, MATLAB

Microsoft Products

MS Office, MS Access, MS Outlook.

Operating Systems

Windows 2000/NT/98/95, Sun Solaris, HP-Unix, Red Hat Linux

QUALIFICATIONS:

• Bachelor OF Technology

PROFESSIONAL EXPERIENCE:

Client: Confidential, Summit - NJ Aug'07 - Present

Position: Statistical Programmer-Clinical Trials

Project: 6-Month Extension Trial of Asenapine with Olanzapine in Negative Symptom Patients Who Completed the First 6- Month Trial.

Description

Study type

Interventional

Study Design

Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study.

Official Title

A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013.

Phase

Phase III

Responsibilities:

• Thorough knowledge in SAS Programming, merging SAS Data Sets, Macro Facility, Preparing Data, PROCs, Producing Reports, SAS, SAS Formats, SAS Functions, Storing and Managing Data in SAS Files.
• Developed programs to generate tables and supporting Listings, Integrated Safety Reporting and Electronic Submissions to Regulatory authorities.
• Worked with Data Managers for ensuring the Data Integrity and did Data Cleaning, Data Validation and produced TLG's as per the requirement of Clinical and Data Management Department (DMD).
• Provided statistical programming expertise in production of Reports, CRT's (Case Report Tabulation/Analysis Datasets), Graphics, Summaries and Listings from clinical trial data.
• Participated in documentation and data programs archiving.
• Comprehensive skills in working with SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS etc. in windows and Unix environment.
• Contributed to the preparation of Statistical Analysis Plans. Prepared, documented and tested required programs and procedure data displays in an efficient manner for inclusion in integrated clinical statistical reports and other similar reports.
• Created CRT Datasets used for FDA Submissions .
• Good working knowledge in CDISC standards like STDM,ADAM.
• Worked with different clinical trials data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory, and Physical examination.
• Wrote SQL for different conditions.
• Worked closely with Data Management Group to create data cleaning and data validation listings.
• Performed QC, Data Validation and Edit Checks using various procedures and Macro facility.
• Quality assurance checks to support cleaning of clinical data using put statement and various Proc's.
• SAS Macros were extensively used in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Thorough Knowledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel. Also possess good working knowledge in Internet based access and database Usage.
• Produced ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Used Data _Null_ technique for producing highly formatted and highly customized reports.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation and further analysis.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports.

Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, SAS/connect, MS-EXCEL, HTML, Windows NT and Solaris 2.6.

Client: Confidential, PA Feb'06 - Jul'07

Position: SAS programmer

Project: A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise.

Description

Study type

Interventional

Study Design

Treatment Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study.

Official Title

A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm.

Phase

Phase IV

Responsibilities:

• Generated Tables, Listings and Graphs using various procedures like Proc Freq, Proc Report, Proc Tabulate, Proc Univariate, Data _null_, and Proc Gplot.
• Experienced in validating programs and in writing competing codes to re-check the statistical values of tables.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports.
• Successfully designed and implemented statistical reporting processes.
• Performed Data Validation and Data cleaning by Peer-Reviewing.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions.
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Produced highly formatted and highly customized reports using Data _Null_.
• Provided SAS programming and statistical support to Statisticians.
• Worked with Data Managers for ensuring the Data Integrity and did Data Cleaning, Data Validation and produced TLG's as per the requirement of Clinical and Data Management Department.
• Successfully validated TLG's and CRT's through independent validation using Proc compare and departmental standard macros.
• Expertise in Integration (Pooling) of datasets from different studies for further analysis.
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Successfully handled multi-projects / task at a time.

Environment:SAS 8.2 (PC, UNIX), SAS/BASE, SAS/MACROS, PROC SQL, SAS/STAT, SAS/GRAPH

Client: Confidential, Chennai - India Mar' 05 - Jan'06
Position: SAS Programmer/Analyst - Clinical Trials

Project: A Study to Evaluate the Efficacy and Safety of Herceptin (Trastuzumab) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer.

Description

Study type

Interventional

Study Design

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study.

Official Title

A Randomized, Open-Label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-Free Survival in Patients With HER2-Positive and Hormone-Receptor Positive Metastatic Breast Cancer.

Responsibilities:

• Maintained appropriate application reference documentation.
• Provided SAS programming and statistical support to Clinical studies
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Using SAS/STAT to response-surface regression modeling to examine how acidity and mixing time affect the yield of new chemicals.
• Perform an exact test to evaluate the success of a new pain medication on headache relief in a small study using SAS/STAT.
• Generated graphs using SAS/GRAPH and SAS Graphics Editor.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Developed SAS macros for data cleaning and Reporting and to support routing processing.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports
• Convert MS-Word documents and Excel tables into SAS data sets.
• Read data from Oracle, Excel and flat files into SAS software. Developed SAS code to clean the invalid data from the database. Creating Summary Reports and Tabular Reports using Proc Report.
• Used SAS/STAT software for Statistical Analysis, procedures and reports.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT

Client: Confidential, HYD - India. Jun' 04 - Feb'05

Position: SAS Programmer/Analyst - Clinical Trials

Project: 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peritoneal Dialysis Patients.

Description

Study type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.

Official Title

A Multi-Center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-Deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Responsibilities:

• Performed relevant statistical analysis of surveys and economic data captured during Clinical Trials.
• Worked with different clinical trials data like Demographics, Adverse Event (AE),
• Serious Adverse Event (SAE), Laboratory and Physical Examination.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate PROC UNIVARIATE, Data _null_, Proc Plot, and Proc Gplot
• Performed Data Validation and Data Cleaning on Clinical data using procedures like Proc Freq, Proc Means, and Proc Univariate.
• Used SAS Macros extensively in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Wrote SQL Queries to check data for different conditions like duplicate values and missing values.
• Created and implemented statistical analysis plans and specification documents.
• Integrated with Clinical, Regulatory and Data Management colleagues to coordinate collection and reporting of clinical studies.
• Developed permanent SAS formats, templates and libraries.
• Prepared list of efficacy data for statistical analysis.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Generated graphs using SAS/GRAPH.
• Knowledge of database.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT