SUMMARY

• 7 years of extensive experience in analysis, design, development of Statistical data models including data extraction, manipulation, writing macros and reporting on various projects, for Healthcare, Clinical and Financial companies.
• Strong experience in Clinical Data Analysis, Generating Statistical Analysis Files, Lists, Tables, Graphs, Validations, Documentation, FDA Electronic Submissions. Good Experience in Phase I, II, & III Clinical Drug Trials studies.
• Good command in creation of CDISC SDTM datasets and in derivation of ADaM datasets and Define.XML.
• Experience in implementing SAS procedures, macros, and applications for data cleaning, reporting, and documentation. Developed SAS Macros for generic coding and reusable modules.
• Developed new or modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs
• Involved in pooling of data from multiple studies and generating Tables/Listings/Graphs for Summary of Clinical Safety (SCS) for FDA Submission.
• Good experience in generating ISS and ISE reports for the NDA submission to FDA.
• Good Interaction with Clinical Data Management, Statisticians, Medical Writers and Regulatory team members.
• Excellent understanding of Bio - statistical work flow: Starting from Raw Datasets to creation of submission package i.e., CRT packages.
• Experience in therapeutic areas Central Nervous System, Oncology, Hematology, Virology, and Epidemiology.
• Responsible for writing and debugging statistical programming, documented programming procedures and involved in coding
• Worked in conjunction with CROs to perform Clinical Data Analysis for Phase I - III.
• Familiar with 21 CFR Part 11 compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) and Coding Dictionaries such as MedDRA and WHODrug.
• Extensive experience in Base SAS, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS/ODS.
• Comprehensive skills in working in UNIX and Windows environments.
• Skilled in generating reports to communicate key findings and articulate strategic implications using PROC PRINT, PROC REPORT, PROC TABULATE, PROC MEAN, PROC GPLOT, and PROC GCHART.
• Ability to handle multiple projects with speed blended accuracy and work independently with minimal supervision.
• Self-motivated individual with strong Technical & Analytical skills. Always keen and eager to face up to challenges by means of novel and innovative ideas.

TECHNICAL SKILLS

SAS Tools: SAS v8.2/9.1.3/9.2/9.3, SAS/BASE, SAS/MACROS, SAS/ACCESS

SAS Procedures: SQL, REPORT, MEANS, UNIVARIATE, CORR, REG

Languages: SAS, SQL, HTML

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

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

PROFESSIONAL EXPERIENCE

SAS Clinical Programmer

Confidential, KS

Responsibilities:

• Developed SDTM data mapping and created SDTM datasets as per CDISC standards.
• Extract and transform the raw data into analysis dataset in the desired format. Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) and develop programs to create TLG’s as per the SAP shell.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for multiple trials.
• Designed tables, listings and graphs for safety and efficacy reports. Collected requirements from statisticians, prepared requirement documents, follow up and develop new macros as per statistician’s request.
• Produced analysis ready datasets using standard set of macros and custom macros based on CDISC standards.
• Extracted and analyzed data from the database using SAS/Access, SAS/SQL PROCEDURES and created SAS datasets. Used Proc SQL to retrieve, update and report on information from SAS Datasets and databases
• Involved in the validation of codes written by other team members

SAS Programmer

Confidential, Danbury, CT

Responsibilities:

• Involved in development and enhancements of SAS Programs for Phase I, II clinical trials.
• Designed process flow diagrams with the input data sets used and the techniques that would be used to get the desired output.
• Generated reports, tables, and summaries for Integrated Summaries of safety (ISS), Efficacy (ISE) for FDA submission.
• Extensively involved in Clinical Data Analysis and preparation of SAS datasets, reports, tables, listings, graphs and summaries according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Worked with Biostatisticians and Data Management team in resolving data issues.
• Worked with statistical quality assurance group and program validation for each project.
• Used Proc SQL, Proc import, Proc export statements to load SAS data sets from and to Oracle.
• Wrote efficient SAS templates and Modifying Data Mining Queries using SAS/BASE, SAS/MACROS & SAS/SQL and validating the data before use the same for final analysis.
• Managed wing-to-wing delivery of Healthcare Insurance fraud reports to other teams to analyze and recover from providers.
• Performing data analysis, data migration, data preparation, graphical presentation, Statistical analysis, reporting, validation and Documentation
• Used Macro routines to convert .xls, .rtf and .txt files to produce SAS reports and graphs.
• Retrieved the Actuarial data and convert them into SAS readable format. Make the SAS data sets, analyze data as per given requirement.
• Developing SAS programs using SAS/BASE, SAS/SQL, SAS/STAT, SAS/ACCESS and SAS/MACROS, etc for statistical analysis and data displays
• Constructed, tested, and validated statistical models. Develop programs and perform unit test using SAS. Created robust and efficient analytical data sets.

SAS Programmer/Analyst

Confidential, Nashville, TN

Responsibilities:

• Extracting financial data from the database using SAS/Access, SAS SQL, SAS/Connect, Procedure and create SAS permanent data sets in SAS library.
• Creating SAS Views from tables in Database using SAS/Access, and analyze data.
• Retrieved the financial data from flat files received from the vendors, convert them into SAS readable format. Make the SAS data sets, analyze data as per given requirement.
• Write the SAS code and run those data sets to produce necessary financial reports by using SAS/STAT Procedures such as PROC Freq, PROC Tabulate, Proc Univariate, and PROC ANOVA.
• Created required financial reports using analysis output and export them to other environments or the web using various SAS method like create delimited, text files, ODBC, ODS having formats such as HTML, RTF, or XML.
• Scheduled and managed jobs with AutoSys job management system to ensure job streams flowed smoothly.
• Coded SAS programs with the use of Base SAS and SAS/Macros for ad hoc jobs.
• Created SAS datasets from Oracle database with random sampling technique and created Oracle tables from SAS datasets by using SAS Macros
• Created large datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE
• Used SAS/Macro facility to create macros for statistical analysis, reporting results and data extraction
• Generated HTML, Listings, EXCEL and RTF reports for presenting findings of various statistical PROCEDURES using PROCEDURES like PROC REPORT, PROC PRINT, PROC FREQ and also SAS ODS