PROFESSIONAL SUMMARY:

• Certified Statistical SAS Base Programmer with overall experience of FIVE years working with SAS and SAS tools emphasizing on analysis, program development, QC and validation in life science and healthcare industries on Windows and UNIX environment.
• Experience in multiple databases such as Oracle Clinical, DB2, MS SQL Server, and MS Access
• Proficient in using ODBC to connect SAS System with relational database management systems, such as Microsoft SQL and Oracle, to retrieve data and create SAS datasets
• Extensive experience with clinical data analysis: analyzing clinical data, creating tables, listing and generating reports and graphs.
• Performed data validation and developed study specific edit checks specifications. Used statistical procedures like Proc freq, means and univariate and compare.
• Created Ad - hoc reports before the Database Lock (DBL).Created Ad-hoc reports and summary reports using report and tabulate procedures.
• Familiar with the creation of .XPT files (transport files), DDF files (Data definition) for E-submission
• Good working knowledge on manipulation procedures like PROC transpose, append, datasets
• Created safety and efficacy Analysis/Derived Data sets from raw data sets. Experience in creating analysis datasets for various raw datasets
• Knowledge in determining Power and Sample size with Proc Power.
• Experience in scheduling Randomization Designs by Proc Plan and Proc Surveyselect.
• Created transport files for CRO’S/Sponsors Submission using procedures Cport and Cimport
• Worked with the team in validating the ISS and ISE datasets and preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports. Created HTML, PDF and RTF reports using SAS Output Delivery System (ODS).
• Good working knowledge of clinical trials data like Demographic (DM), Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Data (LAB Data), PK parameters.
• Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs.
• Experience in configuring PROC CDISC in SAS, familiar with CDISC SDTM, ADAM model, domains (Events, Findings, Intervention, and Special Purpose) and Open CDISC for validation. Modified the code and created CDISC compliant datasets.
• Worked on Mapping to meet SDTM standards using open CDISC Validation tool.
• Proficient in understanding of Study Protocols, SAP (Statistical analysis plan), and CRF.
• Solid knowledge of CFR codes, MedDRA, FDA protocols and ICH regulations applicable to the design, analysis and reporting of clinical trials and study submittals
• Exceptional problem solving skills for delivering useful and prudent solution. Excellent written and communication skills, good team player and always open to learn.

TECHNICAL SKILLS:

Statistical Software: SAS EG, SAS v 9.x, SAS/Base, SAS/Stat, SAS/Graph,SAS/SQL,SAS/Access, SAS/Connect, SAS/ODS, SAS/Macros,SAS Viewer.

Operating System: MS Windows /98/2000/XP/7/VISTA, UNIX

Programming Tools: SAS, SAS Enterprise Guide, SAS Viewer, SQL, Open CDISC Validator.

SAS Procs: SQL, REPORT, TABULATE, MEANS, UNIVARIATE, CORR, REG, FREQ, CHART, SORT, SUMMARY, CONTENTS, FORMAT, IMPORT AND EXPORT, APPEND, TRANSPOSE, ANOVA, PRINT

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

Database: Oracle, DB2, Clin-Trial, MS ACCESS, ORACLE Clinical

PROFESSIONAL EXPERIENCE:

Confidential, New Brunswick, NJ

Sr. Clinical SAS Programmer

Responsibilities:

• Worked on Clinical Trials data like Demographic data, Adverse Events (AE), laboratory data (LB), Physical Examination (PE) and vital signs (VS).
• Reviewed clinical study protocol, case report form (CRF), annotated the CRF and provided comments for electronic CRF (eCRF).
• Validated the edit check program and the reports for quality control process.
• Reviewed statistical analysis plan, mock-up’s/shells/templates, provided comments as needed.
• Familiar with updating mock-up as per new study design.
• Referring the statistical analysis plan (SAP), analysis dataset specification was developed and developed analysis dataset programs.
• Validated and maintained status on quality control document for the team, validation has been performed as specified in the QC tracking sheet.
• Generated safety, efficacy, and graphs as mentioned in the template and validated as per the QC tracking sheet, used SAS Output Delivery system (ODS) for generating reports in specific output formats like RTF, PDF, and HTML.
• Used, customized, developed company/therapy/study level macros for generating tables, listings, graphs.
• Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Converting the analyzed datasets into transport (.XPT) and data definition documents (DDD) files for e-submission to FDA.
• Produced accurate, precise tables and graphs for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part 11, FDA and other regulatory compliance.
• Reviewed data to verify integrity and consistency for completeness, accuracy and suitability, including data adherence to protocol, data coding integrity, reliability of collection and interpretation
• Performed Mapping data with the target data following CDISC standards .
• Familiar with different classes and several domains related to CDISC SDTM standards

Environment: Windows 2003/XP/7, Oracle, Base SAS, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS.

Confidential, Wilmington, DE

Clinical SAS programmer

Responsibilities:

• Involved in managing randomized phase II and III clinical trials data.
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Extracting Oracle data from FTP server on daily basis and importing the data and converting into SAS datasets.
• Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
• 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.
• Handled dropouts and missing data by using traditional approach of generating Last Observation Carried Forward (LOCF) data on visit wise data
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission;
• Modified macros for report generation using SAS Macros as per the statistician’s requirements.
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GHART.
• Wrote programs in SAS to generate reports, creating RTF, HTML listings, tables and reports using SAS/ ODS for Ad-Hoc report generation.

Environment: Oracle Clinical, SAS/BASE, SAS/ODS, SAS/Connect, SAS/MACRO, SAS/STAT, SAS/SQL, ORACLE, Access, Excel, DB2

Confidential

SAS Programmer

Responsibilities:

• Retrieved tables from Oracle and DB2 databases using SQL Pass through Facility. Ensure all required data has been extracted from server for process.
• Created Analysis Datasets, Summary Tables, Listings, and Plots according to the specifications of the study for statistical analysis.
• Created new and modified existing SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Developed several ad hoc SAS programs to create summaries and listings.
• Modified existing datasets using data statements such as SET, MERGE and PROC SORT.
• Tested and debugged existing MACROS.
• Extensively used PROC REPORT and PROC TABULATE to create reports.
• Generated safety tables, which also involved in analyzing data and generating Reports.
• Created reports using the DATA NULL and the PROC REPORT for the submission as per the FDA regulations and company standards.
• Validated SAS data sets using PROC COMPARE.
• Formatted RTF and PDF reports using SAS/ODS (Output Delivery System).
• Prepared extensive summary for clinical research data.
• Performed quality control checks on tables, listing etc generated by other team members

Environment: SAS/BASE, SAS/ODS, SAS/MACRO, SAS/STAT, SAS/SQL, ORACLE, Access, Excel, DB2.

Confidential

Bio-Clinical Research

Responsibilities:

• Provided statistical and computing support for Phase II and III clinical studies.
• Converted legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Performed Data mapping from non-CDISC SDTM to SDTM and data mapping from SDTM to ADaM standards.
• Created CDISC Domain Specifications and Data Definition (Define.xml) Documents.
• Validated CDISC SDTM Domains using Proc CDISC Procedure.
• Generated tables, listings and figures (TFLs), including Patient Demography and Characteristics, Adverse Events, Laboratory etc., based on Statistical Analysis Plan (SAP) and Case Report Forms (CRF).
• Involved in generating the summary tables required in submission of ISS and ISE as per FDA regulations.
• Generated summary reports, listing and graphs (TFLs) using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GCHART.
• Created Custom Reports using DATA NULL and PUT Statements.
• Used SAS/GRAPH for proficient illustration of derived results.
• Utilized SAS ODS to produce reports in different formats like HTML, PDF, and RTF.
• Experience in identifying and solving technical problems

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/ODS