SUMMARY

• 7+ years of experience in Statistical Analysis Software (SAS) programming for developing and implementing various applications in the pharmaceutical industries.
• Solid experience and excellent command in various SAS procedures and tools like SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/ CONNECT, SAS/SQL and PL/SQL.
• In - depth work experience in generating tables, listings, and graphs by following the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP), and departmental guidelines.
• Thorough knowledge of statistical analysis techniques for clinical studies, and excellent experience in analyzing safety & efficacy data for Phases (I-III) of clinical trials.
• Having excellent command in producing reports employing various SAS procedures like Proc Print, Proc Report, Proc Tabulate, Proc Mean, Proc Univariate, Proc Transpose, Proc SQL, Proc Access, Proc Connect, Data NULL
• Expertise in storing and managing data in SAS files, merging SAS data sets, using ARRAYS and MACROS, SAS procedures (PROCs), PROC SQLs, SAS Formats, and SAS Informats.
• Experience in data transformations & edit check and commanding experience in analyzing Case Report Form (CRF) data.
• Experience in individually mapping raw dataset to CDISC- SDTM ADaM data structure.
• Extensively used Proc Means, Proc Freq, Proc Univariate, Proc Reg, Proc Anova, Proc Glm, Proc Manova, Proc Corr, and Proc Summary to perform descriptive statistics
• Knowledgeable in CRF-Annotation, ISS, ISE, NDA, ANDA, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines
• Extensively used SAS ODS to generate reports in different file formats like RTF, HTML, PDF and Excel files.
• Working knowledge ofGeneral linear models, Categorical data analysis, Survival analysis, Multivariate analysis.
• Experienced in working in different therapeutic areas such as Oncology, Cardiovascular & Metabolic diseases, Immunology, Weight management, Dermatology, Infectious diseases etc.
• Excellent knowledge and experience in creating analysis clinical trials datasets like Demographic (DM), Adverse Event (AE), Electro Cardiogram (EC), Subject Characteristic (SC), Laboratory (LB) and Vital Sign Data (VS) and other complex elements
• Good understanding on dictionaries like WHO drug and MEDRA.
• Excellent communication and interpersonal skills and accustomed working in challenging environments under deadlines, excellent analytical and problem solving skills.

TECHNICAL SKILLS

SAS Components: SAS v8.2/9/9.2,9.3, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS/ODS

SAS Procedures: Proc Report, Proc Tabulate, Proc Transpose, Proc Format, Proc Reg, Proc Glm, Proc Anova, Proc Contents, Proc Summary, Proc Sort, Proc Freq, Proc Univariate, Proc Means, Proc Print, Proc Chart, Proc Copy, Proc Datasets

Languages: SAS, SQL, PL/SQL, HTML, XML

RDBMS: Oracle Clinical, MS Access, DB2, SQL Server

Office Tools: MS office 97/2000/2003 , Word, Excel and PowerPoint

Operating Systems: Windows XP/2000/NT/98,UNIX

PROFESSIONAL EXPERIENCE

Confidential, California

Sr. Clinical SAS Programmer

Responsibilities:

• Actively involved in analysis of Phase III Clinical Trials data and extended my support through generation of listing tables, summary tables, and graphs for preparation of clinical study reports and regulatory submissions.
• Developing programs in SAS Base for converting the Oracle Data for a phase III study into SAS datasets using SQL pass through facility and libname facility.
• Generated SDTM data sets for AE (Adverse Events), MH (Medical History), DM (Demographics), PE (Physical Examination), VS (Vital Signs), SC (Subject Characteristic), LB (Laboratory)
• Creation of ISS/ISE reports and files for E-Submission and IND (Investigational New Drug) Submissions.
• Set up the SAS/SHARE to make the SAS files accessible to many users across the department.
• Used SAS/GRAPH to present data analysis-using PROC (GCHART, GPLOT, GCONTOUR etc.)
• Used SAS/STAT for descriptive statistics analysis- ANOVA, Frequency Distributions, Proc Means, Proc Univariate, Proc Reg and Proc Glm.
• Carried out semi-automated conversion of non CDISC compliant datasets by using SAS MACRO functions. Dataset columns were converted into rows to support CDISC naming conventions.
• Created reports in the style format (RTF, PDF, XML, Excel and HTML) using ODS statements. The generated reports were reviewed by the statisticians and sent to FDA.
• Extensively handled MACROS and SAS BASE procedures such as Proc Print, Proc Tabulate, Proc Report, Proc Summary, Proc Sql, Proc Means, Proc Freq, Proc Transpose, Proc Contents, and Proc Format.
• Generated reports on AE (Adverse Events) and SAE (Serious Adverse Events) as a part of clinical data management process. Developed reports using Proc Report, Proc Tabulate and Data Null .
• Participate as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities.

Environment: SAS 9.3, SAS/Enterprise Guide, PC-SAS, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/CONNECT, SAS/MACROS, SAS/ACCESS, SharePoint, Oracle 11g, Toad 11.6, UNIX, WINDOWS 7, Nextrails Prism, Putty, Reflection X.

Confidential, Rahway, NJ

SAS Programmer

Responsibilities:

• Worked with a team of bio-statisticians and data managers for generating safety and efficacy tables across Phase II and III oncology clinical studies.
• Designed and developed statistical summary tables, SAS datasets, SAS reports, listings and graphs, for IND and NDA submissions.
• Created and modified SAS macros for data cleaning, validation, analysis and report generation.
• Wrote code using SAS/Base and SAS/Macros to extract data from Oracle database, flat file, excel file.
• Developed and improved the efficiency of programs through the use of SAS macros.
• Used many Base SAS procedures for analysis, management, presentation and access of the data.
• Modified standard programs to generate data sets for statistical data analysis, generate listings, summaries, tables, graphs and reports for analyzing clinical trial data results in compliance with relevant SOPs as per SAP.
• 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.
• Effectively developed SAS code for modeling data and implemented SAS/STAT procedures such as Proc Lifetest, Proc Lifereg, Proc Phreg, Proc Reg and Proc Glm for survival analysis, logistic regression analysis and other statistical analyses.
• Creating routine and ad-hoc reports using Proc Print, Proc Freq, Proc Chart and Proc Report.
• Designed and developed CDISC SDTM mapping of clinical trial data to generate SAS compliant datasets as per CDISC standards.
• Extensively using Proc Gplot and Proc Gchart for generating graphs and plots.
• Designed and created SAS datasets from various sources like Excel datasheets, flat files and Oracle, created summary reports from existing SAS datasets as per SAP.
• Formatted HTML, XML, RTF and PDF reports, using SAS Output Delivery System (ODS).
• Preliminary data validation of clinical trial data using PROC COMPARE.
• Making summary presentations of business highlights to senior management.
• Documenting process flow, improving and updating procedures for existing SAS applications.

Environment: SAS/BASE, SAS/STAT, SAS/MACROS, SAS, SAS/Enterprise Guide, SAS/SQL, SAS/ODS, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, Oracle, SQL Server, WinSQL, MS Excel, MS Access, Nextrial Prism, UNIX, Reflection X, IP Switch, WINDOWS

Confidential, Sandiego, CA

SAS Clinical Programmer

Responsibilities:

• Provided SAS Programming and analysis support for phase I & III clinical trials
• Co-worked with statisticians as a SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.
• Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Extracted data from ORACLE database and involved in cleaning the data using various edit check techniques.
• Used procedures like Proc Transpose, and Proc Sort, in data transformation and manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• Produced Ad hoc reports of various kinds like listings, tables, and figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Proc Summary, Proc Print, Data Null technique, and Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• Validated analysis data sets and SAS outputs with other programmers’ outputs and mockups in SAP using Proc Compare, Proc Contents, and Proc Freq. Created formats for the coded data and used Proc Sql for data validation.
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.

Environment: SAS/BASE, SAS/STAT, SAS/MACROS, SAS, SAS/Enterprise Guide, SAS/SQL, SAS/ODS, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, Oracle, SQL Server, WinSQL, MS Excel, MS Access, Nextrial Prism, UNIX, Reflection X, IP Switch, WINDOWS

Confidential, Knoxville, TN

SAS Programmer/Analyst

Responsibilities:

• Actively involved in analysis of Phase I, II & III trails in oncology and dermatology studies to identify and compare the safety and efficacy of a new molecule.
• Performed data analysis, statistical analysis, predictive analysis and generated reports, listings and graphs using SAS tools e.g., SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/ODS, SAS/STAT, SAS/Connect and SAS/Access
• Used SAS Data Step logics to Sort, Merge, Stack, Update and Interleave datasets for producing required analysis of data and used Proc Report to produce required Reports.
• Developed Mappings between Source and Target and Validated Data for missing values and created TLGs based on the requirements.
• Responsible for creating SAS data sets like AE (Adverse Events), MH (Medical History), DM (Demographics), PE (Physical Examination), VS (Vital Signs), SC (Subject Characteristic), LB (Laboratory)
• Extensively handled MACROS and SAS BASE procedures such as Proc Print, Proc Tabulate, Proc Report, Proc Summary, Proc Sql, Proc Means, Proc Freq, Proc
• Transpose, Proc Contents, and Proc Format.
• Wrote independent SAS programs to create, validate TLG, analysis datasets, and SAS standard macros for Phase II, III studies.
• Created Kaplan-Meier Survival Curves using PROC LIFETEST and PROC GPLOT in SAS.
• Maintained studies document as per the FDA rules and 21 CFR parts 11 regulations.
• Extensively performed Data Cleansing and Data Validation by analyzing the raw data and writing SAS Program and SAS Macros
• Interacted with project team members to understand reporting requirements.
• Generated tables using Proc Report, Proc Tabulate, and Proc Print procedures.
• Used SAS/ODS to generate reports on HTML web format as well as in RTF and PDF formats.
• Extensively used Base SAS, SAS/Macros, SAS/Graph, and SAS/Stat.
• Performed statistical analysis and created reports using Proc Freq, Proc Report, Proc Tabulate, Proc Mean, Proc Univariate, Proc Transpose, Proc Format and suitable options for these procedures.
• Used SAS DATA NULL and PUT statements to create the customized reports.
• Validated, documented and tested component programs in an efficient manner for inclusion in integrated reports.
• Provided programming support in compliance with relevant SOPs and working practices.

Environment: SAS 9, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/CONNECT, SAS/ACCESS, SAS/ODS, WinSQL, MS Access, MS Office, SQL Server, Nextrails Prism, WINDOWS.

Confidential

Jr. SAS Programmer

Responsibilities:

• Worked on clinical trial data from Phase I, PK/PD and Bioequivalence studies.
• Converted MS-Word documents and EXCEL tables into SAS data sets.
• Created web reports in HTML format using SAS/ODS.
• Using SAS/STAT to perform analysis of variance for balanced or unbalanced designs, multivariate analysis of variance, and repeated measurements analysis of variance.
• Create electronic data sets (i.e., SAS transport files) for electronic submission.
• Ensured quality of dataset at the protocol level while working to deliver competitive advantage and cost efficiency to the company as a whole.
• Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) and other regulatory compliance.
• Involved in preparing analysis plans, data analysis and statistical report writing presentations to FDA and programming of patient profiles for statistical reports.
• Created SAS Customized Reports using the Data Null technique for FDA evaluations.
• Generated graphs using SAS/GRAPH and the SAS Graphics Editor.
• Developed SAS macros for data cleaning and Reporting and to support routing processing.
• Used PROC REPORT to generate reports.

Environment: SAS 9.1, 9.2 on UNIX and Windows with following modules, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/SHARE, SAS/MACROS, SAS/ACCESS. SAS/CONNECT, PL/SQL, Reflection X, Putty, KEA X, IPSwitch, MS SQL Studio, SharePoint, PVCS, MS Visio.