SUMMARY

• SAS Advanced Certified Programmer with around 8 years of experience in Analysis, Design, Development, Implementation and Testing of various clinical projects using SAS tools in Pharmaceutical Industry in all phases (I - IV) of Clinical trials.
• Experience in Integrated Summaries of Safety (ISS/ISE) and creating Ad-hoc reports.
• Reviewed and provided inputs to CRF's, statistical analysis plans and analysis datasets.
• Extracted raw data from CRF files.
• Extensively used edit check macro for data cleaning and data check.
• Thorough knowledge and experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/ODS and SAS/GRAPH.
• Strong Experience in creating and validating SDTM and ADaM domains using raw datasets by different SAS Procedures and standard macros.
• Performed production review and created test cases for utility macros.
• Use created analysis datasets, generated Tables, Listings and Graphs (TLGs) as per specifications and in compliance with FDA.
• Formatted HTML, XML, RTF and PDF reports usingSAS output delivery system (ODS).
• Strong experience in using PROC REPORT andSAS/ODS for generating Reports in desired format from the processed data.
• Created CRT's (Case Report Tabulations) using CDISC standards for submissions to the FDA.
• Thorough knowledge and understanding of Code of Federal Regulations (21CFR Part 11), GCP, ICH, FDA and other regulatory guidelines.
• Excellent interpersonal skills; capable of handling multiple tasks and priorities; self-motivated; ability to work in a fast paced environment and under deadlines.
• Extensive work experience with Blood Screening, Oncology, Metabolic Disorders, Neurosciences, and Inflammation studies.

TECHNICAL SKILLS

Operating systems: Windows, UNIX.

SAS Tools: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, and SAS/CONNECT.

SAS Procedures: SQL, Sort, Report, Transpose, Means, Freq, Summary, Format, Univariate, GLM, Logistic, Lifetest, Gplot, Gchart, SGplot, SQL, Append, Import, Export, Datasets, Catalog.

Databases: MS Access, MS Excel, Oracle Clinical.

Others: MSOffice, SQL, MATLAB.

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential, PA

Responsibilities:

• Contributed in study-related activities such as review of CRF, and SDTM and ADaM specification document.
• Reviewed edits check specifications to ensure data accuracy and data validity/integrity.
• Performed statistical analysis of efficacy endpoints using various SAS procedures such as Univariate, Freq, Glm, Mixed, Logistic, and Lifetest.
• Generated TLGs using ADaM datasets, programming specification documents, SAP and TLG shells.
• Create customized figures for clinical study reports as well as ad-hoc requests using SAS procedures Gplot and Gchart.
• Generated CRT packages and validated them for FDA submission.
• Modified/validated existing SAS macros to report summary as well as descriptive statistics.
• Performed validation of SAS programs and standard macros using company guidelines and communicated findings to the programmer/ biostatistician.
• Generated Ad-hoc reports as required for addition submission to NDA.

Environment: SAS 9.4 & 9.3,SAS/BASE,SAS/MACRO,SAS/SQL,SAS/GRAPH, SAS/SQL, Excel.

Clinical SAS Programmer

Confidential, MN

Responsibilities:

• Participated in the SAS programming for multiple clinical trials and ISS/ISE.
• Created/validated CDISC SDTM and ADaM compliant datasets along with its metadata specifications.
• Reviewed and provided comments for statistical analysis plans and specifications for the mock shells.
• Combined data from multiple studies to create pooled datasets for reporting of ISS/ISE.
• Created standard Safety tables for Adverse Events, Concomitant Medications, Electrocardiograms, Vital Signs, and Labs.
• Generated shift tables, change from baseline tables, and outputs for Efficacy Endpoints.
• Created SAS macros for reporting of the multiple tables across studies and for the similar tables for subgroup analyses.
• Coordinated work on multiple studies simultaneously as per priorities and met all study timelines.
• Produced annotated Survival Curves using Proc Lifetest (Kaplan-Meier method) and Proc Gplot.

Environment: SAS 9.3,SAS/BASE,SAS/STAT, SAS/MACRO,SAS/GRAPH, SAS/SQL, Excel.

SAS Programmer

Confidential, CA

Responsibilities:

• Validated source and analysis datasets using SAS procedures and standard macros.
• Dealt with large blood screening lab data (external and internal) review and analysis.
• Generated and Validated Tables, Listings, and Graphs using different SAS procedures.
• Recommended technical and process solutions that can be used or developed to increase efficiency of project work.
• Adapted to changing circumstances, policies, work assignments, and/or team members.
• Worked multiple studies at same time and deliver them on time.
• Prioritized and delegated tasks based on the importance of the deliverable and awareness of overall timelines in order to efficiently produce high quality deliverables.

Environment: SAS 9.2,SAS/Base,SAS/MACRO,SAS/Graph, SAS/SQL, Excel.

SAS Analyst

Confidential, NJ

Responsibilities:

• Read data from different sources like csv and excel files.
• Performed various business checks on the source data to confirm whether data is correct or not.
• Compared the source data with historical data to get some statistical analysis.
• Performed transformations like Merge, Sort and Update etc. to get the data in required format.
• Created and Validated SDTM and ADaM SAS data sets using CDISC standards as well asSASprocedures like Proc Means, Proc Frequency and Proc Univariate,
• Performed data integrity checks and data cleaning usingSASMACROS and data steps, created HTML outputs with table of contents using ODS HTML.
• Generated and validated TLFs in user required format by using ODS and PROC Report.
• Experienced in handling large volume data.

Environment: SAS 9.1.3, SAS/BASE,SAS/STAT,SAS/SQL,SAS/MACRO,SAS/ACCESS,SAS/ODS, MS Access, Excel.

SAS Analyst

Confidential, NJ

Responsibilities:

• CodingSAS programs with the use ofSAS/Macros for sophisticated use of proc report statements and the ODS.
• Developed programs using SAS/BASE &SAS/MACRO to extract data from oracle tables.
• Used complex macro statements, stored processes and procedures like Proc SQL, Proc Means, Proc Freq, Proc Tabulate.
• Extensively used Proc Report to create complex reports.
• Created customized reports using compute blocks and Call Define statements.
• Created HTML and PDF reports usingSAS - Output Delivery System ODS.
• Created reports using ODS Layout.
• Prepared graphs using the modified data in PROC GCHART for business analysis
• Excellent ability in data query, cleansing, validation and mining.
• Experienced and knowledge using data null and SQL in report generation.
• Analyzed various tables using data manipulation techniques like Merging, Appending, Concatenating and Sorting.

Environment: SAS 9.1.3, SAS/BASE,SAS/MACRO,SAS/SQL,SAS/CONNECT, SAS/ODS.