SUMMARY

• Clinical SAS Programmer with 5+ Years of experience in Development of Conversion specifications and SDTM datasets as per CDISC as well as Client specific implementation standards.
• Development of ADaM datasets as per CDISC standards.
• Producing TLGs by referring to Programming Plan, Statistical Analysis Plan (SAP) &
• Mockup shells in accordance with Standard Operating Principles (SOP).
• Extensive knowledge in all phases of clinical trials (I - IV) in both Pharmaceutical/CRO.
• Well experienced in analysis of clinical trial data and generating reports, graphs, listings, summaries, tables and standard operating procedures based on company standards in compliance with 21 CFR Part 11, FDA and other GCP Guidelines.
• Worked with Multicenter Clinical Trials data, Randomization Process, Double-blind Trials, Statistical Analysis, Data Cleaning, Data Management and Reporting.
• Conceptual understanding in various business requirements in both clinical. Generating the needs by having firm grip over various SAS procedures like proc SQL, proc report, proc tabulate, proc chart, proc format, proc import, proc export, proc print, proc sort, proc compare, proc append, etc.
• Also aware of requirements needed by Regulatory agencies in creating define.pdf and define.xml
• Extensively developed MACROS for several statistical and inferential analysis and maintained existing ones.
• Worked extensively on creation of Analysis Datasets and SDTM domains for
• Demographics, Adverse Events, Lab, and Vital Signs etc. using SAS for Clinical studies.
• Extensive experience in BASE SAS, SAS MACROS, SAS/ACCESS, SAS/GRAPH, SAS-SQL, SAS ODS in Windows and UNIX environments.
• Working experience in Integrated Summaries of Safety (ISS) and Efficacy (ISE) involving pooling of data from 30+ different studies, Dataset Creation and Table Programming.
• Knowledge of CRF-Annotation with respect to various database designs.
• Experience in developing Macros, Data cleaning procedures such as Integrity checks and involved in preparing documentation.
• Outstanding organizational skills including ability to multitask prioritize and manage complex issues.
• Excellent communication skills, Self-starter, good team player, enthusiastic, innovative and challenge oriented.

TECHNICAL SKILLS

Operating systems: UNIX, WINDOWS XP/2000/98/95.

SAS Tools: SAS/Base, SAS/Graph, SAS/SQL, SAS/Access, SAS/ODSSAS Report, SAS Enterprise Guide, SAS Macros.

Database: Oracle Clinical, SQL Server 2000, PL/SQL and MS Access.

MS Office: Word, Excel, PowerPoint, Access and Outlook.

Languages: SQL.

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential, Plymouth Meeting, PA

Responsibilities:

• Created and maintained SASDatasets extracted from Database.
• Worked with different clinicaltrials data, Demographic (DM), Adverse Event (AE), Serious Adverse Event (SAE), Laboratory, and Physical examination.
• Produced analysis datasets for generating Reports.
• Created Tables, Listings, Graphs and customized reports using various procedures PROC Report, PROC Tabulate, Data null and PROC GPLOT.
• Involved in creation of CRT datasets transport files and associating documentation as a part of FDA submissions.
• Created patient narratives and generated .XML outputs for FDA regulatory submissions.
• Involved in writing theSAScode to help in the process of Quality control by implementing various statistical procedures PROC FREQ, PROC MEANS, PROC UNIVARIATE and PROC SUMMARY, PROC Transpose, PROC SQL and PROC PRINT.
• Wrote SQL Queries to debug duplicate values and missing values.
• Used theSASMacro facility to modify existing departmental macros and to replace repetitive codes.
• Extensively used SET, MERGE, UPDATE statements and PROC SQL for adding new variables or observations, creating subsets or modifying datasets.
• Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and provided descriptive statistics using PROC MEANS, FREQ.
• Produced RTF, PDF and HTML formatted files usingSAS /ODS.
• Documented data sets using specifications worked out in conjunction with senior manager.
• Performed Quality Control, Data Validation and Edit Checks using various Procedures and Macro facility.

Environment: SASv9.3/9.4,SAS/BASE,SAS/GRAPH,SAS/MACROS,SAS/SQL,SAS/ODS,SAS/ACCESS, SAS/STAT

Confidential, Long Beach, CA

SAS Clinical Programmer

Responsibilities:

• The project has safety and efficacy data that included different interventions of diabetic drugs in a random population.
• Generated effective methods and implement previously outlined analysis plans.
• CreatedSASBase,SAS/SQL,SAS/Macro,SAS/STAT datasets.
• Built easily maintainedSAScode to solve complex problems in the analysis and reporting clinical trial data and for the review, exchange, transformation, and submission of data.
• Involved in Delivering output using ODS (Output Delivery system)
• Using the Statistical procedures like PROC UNIVARIATE, PROC FREQ, PROC CORR, PROC MEANS, PEOC REG and PROC ANOVA.
• Standardized CRF modules are optimized for specific clinical trials to improve the efficiency in database design, and the production of tables and listings.
• Good knowledge in different phases (phase I to IV) of clinical trials.
• Used Clinical trials data like Demographics (DM), Adverse Events(AE), Laboratory data(LB), Vital Signs(VS) Disposition (DS) and Medical history (MH) etc.
• Generated programming Tables, Listings of Phases I, II, III and IV clinical trial data; required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
• Generating annual safety reports, creating interim safety listings and analyzing which is a part of the company's risk management strategies.
• Experience in extract, transform and loading (ETL) data from different sources.
• Very good experience in analyzing Case Report Forms (CRF) data, Clinical Trials, Clinical Data Analysis, Validations and Documentation.
• Generated TLGs (Tables, Listings and Graphs) for different phases of clinical trials for FDA submission.
• Importing and exporting raw data files in different formats (Excel, CSV, Tab).
• Extensive programming experience with PROC Freq, PROC Report, PROC Tabulate, PROC Transpose, PROC FORMAT and PROC INFORMAT.
• Generated final output’s in required formats (.Lst, Rtf, Html, Pdf) by using SAS/ODS. Tested and debugging existing MACROS.
• Team coordination and willingness to learn.
• Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts.
• Effectively translate statistical concepts and concerns to non-statistical audiences.

Environment: SAS/BASE,SAS/STAT,SAS/SQL,SAS/MACRO,SAS/ACCESS, Excel.

Confidential

Statistical Analyst

Responsibilities:

• Reading data from different sources like .csv, excel, tab delimited files.
• Extracted data from the database using SAS/Access, SAS SQL procedures and create SAS data sets.
• Created datasets and generating reports using PROC REPORT, PROC SQL and MACROS.
• Used Output Delivery System (ODS) facility to write custom safety and efficacy reports in PDF, RTF and HTML formats.
• Unnecessary data and duplicate were reported to client using data null.
• Code, and test SAS programs for the summarization, statistical analysis and reporting.
• Perform various business checks on the source data to confirm whether data is correct or not.
• Compare the source data with historical data to get some statistical analysis.
• Perform transformations like Merge, Sort and Update to get the data in required format.
• Generate Reports in user required format by using ODS and PROC Report.
• SASdata sets are validated usingSASprocedures like Proc Means, Proc Frequency and Proc Univariate.
• Generated outputs with table of contents using ODS HTML.
• Prepared graphs using the modified data for business analysis.
• Creation of Data Sets on the Remote Server.
• Used shell programming to run weekly and monthly reports
• UsedSAS/ACCESS to gather data from RDBMS like TERADATA.
• Coordinating the production of monthly, quarterly, and annual performance reports for senior management.
• Maintained and enhanced existingSASreporting programs for marketing campaigns.
• MaintainedSASstatistical analysis for the products purchased every month.
• Run reporting programs and download the results into EXCEL and build pivot tables.
• Presented the results and statistical reports in PowerPoint for marketing staff.

Environment: SAS/BASE,SAS/STAT,SAS/SQL,SAS/MACRO,SAS/ACCESS,SAS/ODS, MS Access, Excel, TERADATA.

Confidential

SAS Data Analyst

Responsibilities:

• Involved in phases I-III of Clinical Trials as part of clinical research biostatistics and programming department requirement.
• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety updates.
• Rapidly learn to be proficient in the SAS environment, including the use of internally developed SAS macros.
• Take responsibility for and complete work on periodic regulatory submission, such as Data
• Safety Update Reports and Investigator Brochures.
• Design table, listing and figure.
• Ensure compliance with SOPs, work instructions, ICH-GCP and any other applicable local and international regulations.
• Created ad-hoc reports as per FDA and Client requests.
• Produced Reports, Listings, Tabulations and Summaries of the clinical trial data using procedures such as PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC TABULATE, and PROC REG.
• Thoroughly document programs and contribute to external documentation if required.
• Wrote a macro for shift tables of laboratory data with few simple macro parameters which can be used across studies in the company.
• Created SAS macros for treatment Emergent serious AEs tables.
• Worked on Kaplan mire tables and graphs using proc life test.