SUMMARY

• Around 6 years of experience working with SAS and SAS tools emphasizing on analysis, design, developing, testing and implementation of various projects for pharmaceutical and biotech industries.
• Experience in BASE SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS MACROS, SAS/ACCESS, SAS PC, and SAS ODS in Windows and UNIX environments.
• Knowledge of the drug development process with strong experience of analyzing and reporting Phase I, II, and III of clinical trial data.
• Knowledge in preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports for NDA Submissions.
• Involved in mapping and converting the clinical trial data to CDISC standards - SDTM & ADAM.
• Good working knowledge of clinical trials data like Demographic, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Data (LAB), ECG and vital signs.
• Involved in creation of Data Definition Tables (DDT) & SAS Export files (.xpt) for FDA submission
• Validation of datasets and TLGs and peer reviewing of the fellow programmer’s code.
• Proficient in using SAS ODS to produce reports in PDF, HTML, RTF formats for presentation and further analysis.
• Knowledge of drug submission requirements, ICH and FDA guidelines and CDISC standards and 21 CFR Part 11.
• Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generating reports, and created tables, listings and graphs as per SAP.
• Experienced in producing RTF, PDF, HTML and MS Excel formatted files using SAS ODS facility.
• Worked extensively on various SDTM domains such as AE, CM, LB, DM, SE, EG, EX, IE and their SUPPQUAL datasets.
• Developed programs in SAS Base for converting the Oracle Data for a phase I - III study into SAS datasets using SQL Pass through facility.
• Have extensive knowledge on implementing statistical and graphical techniques including linear and nonlinear modeling, time series analysis
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Connect, SAS/Enterprise Guide and has good knowledge of GCP, GPP and US FDA & 21 CFR Part 11, MedDRA guidelines related to generating the Clinical Reports and Electronic records as well.
• Knowledge of Pharmacokinetic and Pharmacodynamics properties of the drug.
• Excellent written and communication skills, self-starter and a good team player.
• Independent working ability and Good team player with excellent organizational and documentation skills with excellent communication and presentation skills.

TECHNICAL SKILLS

Tools: BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/REPORT, SAS/SQL, SAS/CONNECT

SAS Procedures: Print, Means, Univariate, Freq, Sort, Summary, Format, Transpose, Compare, Correlation, Regression, SQL, Tabulate, Import, Export, Life Test, GPlot, GLM, Mixed, CPort, Catalog

Languages: C, C#, SQL

Databases: Oracle Clinical, MS Access.

Other Utilities: Microsoft Office (Excel, Word, Power point )

OS: Windows NT/ XP, UNIX, Windows 7

PROFESSIONAL EXPERIENCE

Confidential, Bridgewater, NJ

Senior SAS Programmer

RESPONSIBILITIES:

• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros.
• Worked in post marketing studies of phase IV
• Provide SAS programming expertise in the production of the derived datasets, tabulations, and cross-study summaries from prescription marketing data.
• Created weekly and monthly topline reports for several drugs and explain the sales growth comparing with the competitors in the market.
• Extensively worked on DDE using SAS to make the excel file open, close, write and save to the correct path in a specified location.
• Made several power points for individual drugs from the excel reports by linking up.
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for data cleaning and Report generation.
• Created datasets in SAS by Using PHAST 2.0 data from SYMPHONY and extracted the reports to excel by using PROC EXPORT.
• Perform several data management programs.
• Perform data pre-processing and dataset preparation for particular statistical analysis, including checking data quality, handling missing value and duplicate key, clean-up duplicate records.
• Provide district ranking and territory ranking to the marketed products by using Proc RANK
• Produced reports by using DDE and provided descriptive statistics using PROC MEANS, PROC FREQ, PROC UNIVARIATE, and PROC TABULATE.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/TOOLS, SAS/BASE, SAS/MACRO and SAS/SQL, SAS/ACCESS.
• Developed SAS macros for data cleaning and Reporting and to support routing processing using SAS to analyze data, statistical tables.
• Performed analysis of datasets by using SAS procedures such as Proc Means, Proc SUMMARY, and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.

Confidential, Foster city, CA

Senior Clinical SAS Programmer

Responsibilities:

• Worked on Phase II and III clinical studies.
• Provide SAS programming support on legacy and ongoing studies
• Work on ISS and ISE pooled datasets and TLGs.
• Create Reviewed and Validated Reports for data cleaning using SAS Edit checks.
• Provide support to data management for data cleaning.
• Use of SAS/BASE, SAS/SQL, SAS/ODS and SAS/MACROS extensively in daily use.
• Develop SAS Macros for Edit checks raw data.
• Create specification for SDTM and ADaM datasets as well as validate them.
• Data transmission and integrity check of the SAS datasets.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Tools, SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
• Produced quality customized reports by using Proc tabulate, Proc report and Proc summary and also provided descriptive statistics using Proc means, proc freq, and proc univariate.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Integrated SAS datasets into Excel using Direct Data Exchange, using SAS to analyze data, statistical tables, listings and graphs for reports.
• Participated in study locks by doing the final analysis of the data and reports. Followed validation process for all the IT systems created.
• Prepared Data Definitions for the studies.
• Developed and implemented complex oracle backend programs by using SQL, PL/SQL
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Reviewed of Clinical data for FDA Submissions.
• Performed analysis by using SAS procedures such as Proc means, Proc UNIVARIATE, and Proc Plot in SAS/STAT, SAS/SQL.

Confidential, Parsippany, NJ

Clinical SAS Programmer.

Responsibilities:

• Created various SDTM datasets and ADAM datasets from raw datasets.
• Worked with Data Management Team in creating several annotation CRF’s.
• Involve and review CRF, SAP, mock shells and specs for SDTM/ADaM generation and provide comments.
• Created/validated various Tables, Listings and Graphs for several studies.
• Created ISS/ISE datasets from the specifications.
• Involved in creating Define.pdf aCRFL for FDA submission.
• Involved in Data Validations/ QC of several datasets and TLG’s.
• Worked on editing and developing several macros as per required studies.
• Extracted raw data from Oracle clinical, Excel and CSV to SAS datasets using PROC SQL and PROC IMPORT.
• Create and written specifications for SDTM datasets according to CDISC.
• Created analysis datasets from raw datasets.
• Developed several study specific macros and had good experience in several macro debugging options.
• Performed Various QC validations for datasets and TLG’s. Created SAS transport files for Electronic Submission.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/TOOLS, SAS/BASE, SAS/MACRO and SAS/GRAPH, SAS/SQL, SAS/ACCESS.
• Retrieve clinical and lab data from Oracle database and generate SAS datasets. Present results to clinical study team.
• Developed SAS macros for data cleaning and Reporting and to support routing processing using SAS to analyze data, statistical tables, listings and graphs for reports.
• Reviewed the Clinical data for FDA Submissions.
• Performed analysis of datasets by using SAS procedures such as Proc Means, Proc UNIVARIATE, and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.

Confidential

Clinical SAS Programmer.

Responsibilities:

• Responsible for analyzing data received involving in data management and validation.
• Writing and developing SAS reports to display results.
• Performing integrated summaries and electronic submission activities.
• Create SAS datasets, tabulations, graphics, and summaries from clinical trial data.
• Create SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
• Create SAS analysis datasets for statistical analysis.
• Review clinical study protocols, data management plans, Case Report Form (CRF).Import data from Excel files into SAS, check and clean up the data and save as SAS datasets by using datasteps,ProcSort,ProcFreq,ProcMeans,SAS/BASE and SAS/ACCESS.
• Manipulate data by using SAS steps and procedures such as Merge, Stack, sub-set, Proc Transpose, Proc Sort, Proc SQL, Proc Format, Proc Freq and Proc Means in SAS/BASE, SAS/SQL .
• Using split plot ANOVA design do analysis by using SAS procedures such as Proc means, Proc UNIVARIATE, Proc GLM and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.
• Create report and presentation by using Proc Report, Proc Plot in SAS/BASE, SAS/GRAPH and SAS/ODS.
• Make SAS programs to create summary reports table to show each group how to involve in baseline, or change from baseline for the treatment in 4, 8, and 12 weeks by using Proc MEANS, Proc FREQ and Proc GPLOT in SAS/Macro, SAS/SQL. SAS/ODS and SAS/GRAPH.

Confidential

Clinical SAS Programmer.

Responsibilities:

• Creating datasets using SAS/ BASE.
• Involved in providing programming support for Clinical Data Coordinators and Statisticians, and data analysis support generating Datasets and Reports for pharmaceutical studies.
• Produced datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE.
• Prepared the data according to client requirements using data management procedures.
• Developed SAS programs for Edit checks.
• Generated Reports for presenting the findings of various statistical procedures using ODS.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Used the SAS Macro facility to produce weekly and monthly report.
• Designed, formatted and customized style, templates and the layout as per the company requirements in accordance with the FDA guidelines.
• Provided Documentation support for the submission of the datasets according to the CDISC standards.