SUMMARY OF QUALIFICATIONS:
- SAS Programmer/Analyst with total of over SEVEN years of experience in SAS Programming and over FOUR years of experience with clinical andpublic health industry. Possess extensive data and statistical analytical skills experience in clinical trials and health care research environment.
- Used various SAS report generating Procedures such as Proc REPORT, Proc SQL, Proc FREQ, Proc MEANS, Proc TABULATE, Proc TRANSPOSE.
- Experienced in BASE SAS, SAS/MACRO, SAS/GRAPH, SAS/SQL, SAS/STAT, SAS/INSIGHT, SAS/ACCESS, SAS/ODS, merging SAS Data Sets, Preparing Data, PROCs, Producing Reports, SAS Formats, SAS Functions, SAS INFORMATs, Storing and Managing Data in SAS Files.
- Well versed with Clinical Trials, Randomization Process, Trial execution, Statistical Analysis, Data capture, Data cleaning, Data Managementand Reporting.
- Developed SAS programs to create and validateanalysis datasets, listings and summary tables of safety and efficacy data for Phase I- IV clinicaltrials.
- Good Understanding of Clinical trials (Phase I - IV), 21 CFR Part11 and GMPs (Good Manufacturing Practices) and Familiar with Clinical Terminologyand regulatory Guidelines.
- Knowledge of Healthcare data and Clinical Trial Data like Demographic Data (DEMOG), Adverse Events (AE), Serious Adverse Events (SAE), Lab and Vital Sign and Healthcare data.
- Proficient in understanding of Study Protocol, Design document, SAP (Statistical Analysis Plan) and CRF (Case report Form).
- Worked with different clinical trials data such as demographics, Adverse Event (AE), Serious Adverse Event (SAE), Lab, ECG, Con-drug, ECOG,Test drug, Vital signs and so on.
- Strong working knowledge in clinical trial data analysis, generating reports and summary tables, listings and graphs as per Statistical Analysis Plan (SAP) and protocol specifications.
- Report generationusing Proc Report, Proc Tabulate, Proc Print and Proc Summary. Creating custom reports using Data _Null_ and ODS.
- Experience with data extraction, data manipulationandperform statistical analysis using various analysis procedures such as Proc Freq, Proc Means, Proc ANOVA, Proc Univariate, Proc GLM and Proc Summary.
- Possess strong ability to quickly debug SAS compiling errors, review SAS code and quickly identify areas of concern. Strong command overStructured Query Language (SQL).
- Successfully increased portability of existing SAS programs by developing stored compiled macros and stored formats. Highly proficient in basic and advanced statistical concepts, data structure and data management principles.
- Design SAS program to validate dataset and compare in organize manner to find discrepancy and create flag variable for Healthcare Data.
- Worked with the health care team and analyzed health care related data using SAS tools to generate reports, tables, listing and graphs. Experience in developing SAS Macros from scratch and developed application for data updates, data cleansing and reporting.
- Experience in Design and building of SAS Programs to analyze and coordinating clinical trial data for generating Reports, Files, Tables and Listing and Healthcare data to send communication to Prescribers and participants.
- Conversion SAS Datasets to various file types including HTML, Excel, PDF, RTF format using SAS/ODS. Used SAS/SQL and Base/SAS merging procedures to join tables.
- Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
- Knowledge of electronic submissions in eCTD format, including ISS/ISE. Familiar with ClinicalTerminology and regulatory Guidelines. 100% Project completion on time while meeting strict timelines and budget requirements.
- Possess good knowledge of CDISC SDTM, FDA and ICH-GCP guidelines with ability to comprehend clinical study documentation (protocols, CRF\'s, etc.). Expertise in storing, reporting and managing data, developing SAS Procedures, Macros and application for data cleaning, reporting and documentation.
- Quick learner and excellent team player, ability to meet deadlines and work under pressure. Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
- Developed tables and figures, for clinical studies and prepared regulatory documents for FDA submissions. Experienced in Database design and Software Development Life Cycle (SDLC).
- Strong communication, motivation, team building, liaison and leadership skills. Excellent communication and presentation skills. Developed and implemented time-saving data analysis techniques.
- Enthusiastic to develop new skills in a dynamic environment. Go-getter attitude and a good team player. Quick learner and ability to meet deadlines and work under pressure. Result oriented, committed and hard working with a quest to learn new technologies and undertake challenging tasks.
- Self-Starter possessing excellent Communication and Analytical skills along with the ability to adapt in a new environment.
SAS Tools: SAS V8.2, V9.1.3, V9.2/BASE SAS, SAS/GRAPH, SAS/MACROS, SAS/ODS, SAS/REPORTS, SAS/ACCESS, SAS/STAT, SAS/ETL, SAS/EG, SAS/CONNECT.
SAS Procs: Print, Means, Univariate, Correlation, Regression, SQL, Report, Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and Gchart, Append, Anova and Print.
Database: SQL and MS Access.
Statistical Software: SPSS and SAS.
Operating Systems: Windows 98/2000/XP/7, UNIX, Linux.
Other Technologies: Microsoft Office (Word, Excel, PowerPoint, Access and Outlook).
Feb '11 - Present Confidential
Clinical SAS Programmer RTP, Durham, NC
Confidential is a global Bio/Pharmaceutical services organization. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting and commercialization services. Worked on the clinical trial data in the generation of various reports for Adverse Effects, Demographics, Labs, Subject Matter Summaries and performed edit checks for ECG data.
- Analyzed three phases (I-III) of the Clinical Trials data in different therapeutic areas. Worked on the summary of clinical data like Demographics, Adverse Events (AE), Labs, Subject Matter Summary and ECG's.
- Extensively involved in clinical data analysis and preparation of SAS Data sets, Listings and tables according to the Statistical Analysis Plan (SAP)and Clinical Protocols. Involved in generation of listings for Adverse Events (AE domain).
- Developed SAS programs using SAS/BASE, SAS/SQL, SAS/MACROS for statistical analysis and data displays. Developed using BASE SAS andSAS/Macros to extract clean and validate data.
- Wrote macros using SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.
- Verified the accuracy and integrity of data by performing validation checks written in SAS and also checked for data related errors, outliers and missing values. Developed SAS Edit checks with Automated Query generation. Developed reports using Proc REPORT.
- Used ODS to display outputs in file formats. Performed QC (Quality Check) extensively on ECG listings. Used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation.
- Attended project team meetings with Clinical Database Managers and Bio-Statistics.
Environment: SAS 9.2, SAS/SQL, Base SAS, SAS/MACROS, UNIX/Windows NT/2000.
Mar '10 - Jan '11 Confidential
Clinical SAS Programmer/Consultant New York
Confidential is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. This project involves the creation of SAS data sets using the raw clinical data for analyzing the Pharmacokinetics, Pharmacodynamics property of the drug, safety and efficacy reports.
- Created, derived and merged and pooled datasets, listings and summary tables for Phase-I and Phase II of clinical trials. The accuracy and integrity of clinical data were verified by performing validation checks written in SAS and checked for data related errors, outliers and missing values.
- Involved in analyzing Pharmacokinetics and Pharmacodynamics Property of the drug using PK/PD Parameters. Macros were written at various instances for automating listings and graphing of clinical data for analysis.
- Programmed edit check procedures to ensure validity of data collected internally. Involved in validating and QC of the efficacy and safety tables. Created SAS reports using the Data _Null_ technique and the PROC Report for the NDA submission as per the FDA regulations and company standards.
Environment: SAS9 (BASE, SQL, ODS, MACROS) UNIX.
Nov '08 - Feb '10 Confidential
Clinical SAS Programmer Lake Bluff, IL
The study was designed to evaluate the safety and antiviral activity (Efficacy) of the Study Drug, an RNAi therapeutic for the treatment of RSV. The top-line results show that the drug was safe and well-tolerated and demonstrated statistically significant antiviral activity. The trial on adult subjects experimentally infected with a wild type clinical strain of RSV. Efficacy measures included the incidence of viral infection and the effects of treatment on the degree of viral infection and resulting clinical symptoms.
- Developed SAS programs to generate baseline, follow-up, drug safety reports form Oracle database. Worked on UNIX environment preparing large data marts according to user requirements. Develop SAS programs to generate data summaries, data listings and safety analysis (SAE reconciliation).
- Statistical Procedures were applied as per the protocols provided by bio statistician using SAS application. Graphical and html reports were generated on demographics, safety and baseline characteristics.
- Provide SAS programming support on conducting & analysis of Safety & efficacy studies for clinical trial data. Developed SAS programs to generate randomization lists, statistical reports and graphs.
- Created CDISC SDTM domain data sets from existing clinical trial data to provide Case Report Tabulation. (CRT) data to a regulatory agency, such as the FDA and ADaM for describing the full protocol of a clinical trial.
- Developed routine SAS MACROs to create tables, graphs and listings for inclusion in clinical study reports and regulatory submissions and maintained existing ones. Develop SAS programs to generate data summaries, data listings and safety analysis that are required for monitoring regulatory purposes.
- Develop SAS programs for creating intermediate data sets, generating statistical reports and graphs as per statistical analysis plan. Migrated and made changes in SAS programs, to make them work in UNIX without losing their functionality.
Environment: SAS 9.x, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, UNIX.
Aug '07 - Oct '08 Confidential
Clinical SAS Programmer/Consultant Old Lyme, CT
Confidential is one of the most innovative, productive and respected scientific research analysis organizations in health care. Primary responsibilities include the production of CDISC SDTM Compliant datasets and specifications, summary tables, figures, listings and statistical analyses for efficacy and safety as well as providing edit checks, data review listings, & validation.
- Worked extensively to generate SAS data sets, statistical reports, monthly reports, listings, safety reports for cross-functional teams for Phase I to IIof Clinical Trial Data.
- Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables,listings and graphs. Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
- Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
- Created SAS Customized Reports using the Data _Null_ technique. SAS/STAT procedures such as UNIVARIATE, FREQ and MEANS were used to carry out analyses and the SAS REPORT procedure is generally used to display results.
- Used SAS ODS to produce HTML, PDF and RTF format files. Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs.
Environment: SAS v.9, SAS/BASE, SAS/SQL, SAS/Macro, SAS/STAT, SAS/Graph, SAS/Report, SAS/ODS.
Sep '06 - Aug '07 Confidential
Clinical SAS Analyst India
Confidential is a biopharmaceutical company focused on developing and commercializing receptor based drugs for Cardiovascular, Central Nervous System, Inflammatory and Metabolic diseases. It includes clinical monitoring, biostatistics and data management etc.
- Developed permanent SAS formats, templates and libraries. Provided SAS programming using SAS Base Procedures and statistical support to Clinical studies. Created and maintained permanent SAS Data Sets that are extracted from databases.
- Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms. Prepared list of efficacy data for statistical analysis. Generated ad-hoc reports and browser viewable reports using SAS/ODS.
- Developed and modified routine SAS macros to create tables and listings for inclusion in Clinical study reports and maintained existing ones. Read data fromExcel and flat files into SAS software. Developed SAS code to clean the invalid data from the database.
- Creating Summary Reportsand Tabular Reports using Proc Report. Extensively worked on PROC REPORT to produce reports for the purpose of validation. Involved in problem solving, data analysis and complex report generations. Documented reports in compliance with regulations.
- Worked with presentation and reporting procedures like FORMAT, REPORT, PRINT, SORT, etc. Used statistical procedures like PROC MEANS, PROC UNIVARIATE and PROC FREQ for analysis.
Environment: Windows, SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, MS Office Word/Excel/Access.
Jul '05 - Aug '06 Confidential
Clinical SAS Programmer India
Confidential is a leading, vertically integrated global pharmaceutical formulation development, manufacturing and marketing company in India. The project involves the creation of SAS dataset using the raw clinical data for analyzing the pharmacokinetics, Pharmacodynamics property of the drug, safety and efficacy report.
- Worked as a primary SAS programmer to analyze initial data sets and create listings and Tables (TLs) for clinical trials. Modified existing datasets usingSet, Merge, Sort and Format Techniques.
- Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
- Modified Tables and Datasets in previous studies according to the requirements of the statisticians. Validated Data and performed quality check control of the displays and datasets according to the different QC levels.
- Worked on the summary of clinical data like Demographic, Adverse Events (AE), Serious Adverse Events (SAE) and Related Adverse Events. Extensively used PROC REPORT to produce reports for the purpose of validation.
- Used statistical procedures like Proc Means, Proc Univariate and Proc Freq for analysis.
Environment: SAS/BASE, SAS/SQL, SAS/ODS, SAS/STAT, Windows, MS Excel.
Doctor of Medicine (MD).
Masters in Public Health (MPH), USA.