SUMMARY

• Over 4 + years of programming experience in developing and implementing various applications for the pharmaceutical, clinical and health industries. Experience includes creation of analysis datasets, generating TLGs with statistical summary of clinical trials data, support for manuscript and publication work, data and report validation.
• Extensive work experience in Data Analysis, and generated Reports, Tables, Listings, Graphs, CRT’s (Case Report Tabulation), and Summaries from clinical trial data and In - depth knowledge of statistical analysis techniques and excellent experience in analyzing safety & efficacy data for clinical trials.
• Experience of working in the area of Clinical Drug Development; knowledge of Protocol Design and Case Report Form.
• Extensively involved in Data cleaning, Verification, Validation Procedures, and Documentation of Trial data as per SOP’s and in compliance with 21 CFR Part 11, by transforming the case report data into the SDTM and ADAM formats of CDISC.
• Good understanding of CRT (Item 11) dataset creation, CDISC, MedDRA, ICH Guidelines, 21CFR PART 11 Rules and Regulations for regulatory submissions.
• Experience in data transformations & edit check and commanding experience in analyzing Case Report Form (CRF) data.
• Proficiency in various SAS tools like SAS/Base, SAS/Stat, SAS/GRAPH, and excellent working knowledge of SAS Procs like proc report, proc freq, proc means, proc tabulate, proc plot, proc chart, proc contents, proc dataset, proc format, proc import, proc export, proc print, and Proc UNIVARIATE.
• Extensively used SAS Data Integration Studio for mapping the clinical data and performed the ETL.
• Hands on experience in importing techniques like SQL pass through facility, SAS Access, SAS Connect and expert in implementing SAS functions and applications for data cleaning, programming, reporting, and documentation.
• Extensively used SAS/MACRO for creating macro variables and macro programs to modify existing SAS program for ease of modification while maintaining consistency of results and also developed SAS/ Macros for generic coding and reusable modules.
• Good experience in storing and manipulating data in SAS files by Merging, Arrays, Formats, Informats, SQL Joins, Proc Datasets, Proc Sort, and Proc Transpose.
• Experienced in producing Excel, RTF, HTML and PDF formatted files using SAS ODS to produce ad-hoc reports for presentation and further analysis.
• Created ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) datasets.
• Excellent communication and interpersonal skills and accustomed to working in challenging and team environments under timelines.
• Extensive experience as a SAS Programmer in Windows & UNIX platforms and expert at Korn Shell (KSH) scripting to automate daily tasks such as monitoring, reporting, archiving, and error handling.

TECHNICAL SKILLS

SAS Tools: SAS /9x, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPHSAS/ SQL, SAS/ACCESS, SAS/ODS

Operating systems: Windows 95/98/2000, Windows XP, UNIX.

Databases: Oracle SQL, Server, MS-Access.

Office Tools: MS Word, Excel, Access, PowerPoint.

Web Tools: HTML, XML

PROFESSIONAL EXPERIENCE

Confidential

SAS Clinical Analyst/Programmer

Responsibilities:

• Involved in Phase I and II of clinical trials and was responsible for creating, testing and maintaining SAS programs for clinical studies according to company standard procedures.
• Created programs in Base SAS for converting the data into SAS datasets using SQL Pass through facility and Imported data from other data sources such as Excel, Access by using proc import and export techniques.
• Performed data validation, quality review of programs coded by other programmers and checked for data consistency by using SQL.
• Performed edit checks on data to support clinical trial integrated reports.
• Developed new and modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Extensively used SAS report generating procedure to generate the data definition tables.
• Generated Tables, Graphs and Listings for inclusion in clinical study reports and regulatory submissions by extensively using Merge, SQL Joins and performed data transpositions in SAS using PROC Transpose and creating analysis datasets.
• Generated highly customized reports using SAS/MACRO facility, PROC REPORT, PROC TABULATE.
• Developed safety tables including Adverse Events (AE), Vital signs, Laboratory values, ECG and Concomitant medications.
• Extensively used SAS/ODS for generating the reports in PDF, RTF and HTML.
• Worked with project manager to analyze the report requirements.
• Performed duties in compliance with Good Clinical Practices, ICH guidelines and company’s SOPs.
• Worked in mapping of clinical trial data from company standard to CDISC standard using Data Integration studio.
• Extensively used Data Null and SAS procedures such as Proc Print, Proc Report, Proc Tabulate, Proc Freq, Proc Means, Proc Summary and Proc Transpose for producing ad-hoc and customized reports and external files.
• Performed data validation and data cleaning to check if the data values are correct or if they conform to the standard set of rules using PROC FREQ
• Good Experience with CDISC models such as SDTM, ADaM and Define.XML to be utilized for data capture, ware housing, and submission.
• Ensured Analysis Data and Programming Code meets regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Reviewed and approved the SOPs documented for the validation protocols
• Worked extensively with statisticians and other programmers in analyzing data and generating analysis datasets, listings, summary reports, tables and graphs.

Environment: SAS 9, Windows, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/ACCESS, SAS/ODS, WINDOWS

Confidential, NewJersey

Clinical SAS Programmer

Responsibilities:

• Worked regularly on extracting data from oracle clinical database through SAS/ACCESS and SQL pass through facility.
• Created datasets by processing the raw data in text files, comma separated files, and Excel spread sheets using INFILE Statement with DSD, DLM, and MISSOVER options and created SAS Macros and Graphs.
• Used SQL extensively for picking specific data, maintained the data by writing the nested queries, having, and joins for generating ad-hoc reports.
• Created automated annotated-case report form (a-CRF) from CRFs provided by clinical Data Management using SAS and medical references dictionaries such as MedRA, WHO Drug.
• Used SAS/Macros facility extensively to create a generic code applicable to create value added datasets for different efficacy parameters of infectious diseases and created tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintaining existing ones.
• Worked in association with QA group to maintain company’s Standard Operating Procedures (SOP).
• Created RTF, PDF and HTML listings, tables and Reports using SAS/ODS and also created Summary and Tabular Reports using Proc Report.
• Created SDTM data sets for safety and efficacy domains and created SAS macros for SDTM mapping.
• Responsible for the implementation and validation of SAS code for Phase II and Phase III study.
• Wrote independent SAS programs to create, validate TLG, analysis datasets, and SAS standard macros for Phase II, III studies
• Utilized the Study Data Tabulation Model (SDTM) Model V1.1 and SDTM IG 3.1.1 for validating data content as per CDISC standards using Proc CDISC
• Worked in mapping of clinical trial data from company standard to CDISC (SDTM) standard in the form 21CFR part11 for FDA submissions.
• Actively involved in documentation and validation of listings output and SAS code.
• Attended project team meetings, worked with bio statisticians, data managers and clinical research managers as appropriate. Reviewed and provided feedback for data integrity plans

Environment: Windows 2000 Server, SAS v9, Oracle clinical, UNIX