SUMMARY

• SAS programmer with 7+ years of experience in Analyzing and Reporting of Clinical Data in various Pharmaceutical and CRO Industries.
• Knowledge of the Drug Development Process in phase I, II and III of clinical trial data.
• Good knowledge on ICH, NDA,IND, FDA - 21 CFR part 11and GCP regulations and guidelines.
• Experienced in using various SAS modules such as SAS/BASE, SAS/STAT, SAS/ODS, SAS/GRAPH and SAS/MACROS.
• Extensively used SAS Procedures and Functions to produce Tables, Listings, Graphs (TLGs)
• Hands on experience in various SAS procedures like PROC SQL, PROC REPORT, PROC FORMAT, PROC TABULATE, PROC TRANSPOSE, PROC UNIVARIATE, PROC ANOVA, PROC SUMMARY, PROC FREQ, PROC APPEND and PROC DATASET etc.
• Experienced in generating Ad-Hoc Reports based on Client Requests.
• Knowledge of CRF- Annotation with respect to various database designs.
• Extensively used SAS/ODS procedures to generate Reports.
• Extensive experience in creating SDTM and Analysis Datasets using SAP and CDISC Standards.
• Involved in generating Clinical Study Report (CSR) and Integrated summary of Safety (ISS) and Efficacy (ISE)
• Reviewed SAP, Protocol and annotated CRF for Clinical Trials.
• Familiar with standard Dictionaries such as MEDRA and WHODRUG
• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.
• Used SAS Macros extensively in the creation of new programs as well as the modification of existing programs to improve ease and consistency of results.
• Involved in file transport as part of Case Report Tabulation(CRT) for regulatory submissions.
• Highly self-motivated and goal-oriented professional to work individually in a team environment.
• An excellent problem-solver, able to quickly grasp complex systems and identify opportunities for improvements and resolution of critical issues.

TECHNICAL SKILLS

SAS Skills: Base SAS v 8/9.1/9.2, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/ODS, SAS/REPORT, SAS/CONNECT, TRANSPOSE, CONTENTS, IMPORT,EXPORT.

Operating Systems: Windows 98, XP, Vista, Windows 7 UNIX.

Office Tools: MS office 97 - 2010, Word, Excel, Power Point, MS ACCESS, MS-Outlooks, MS- Communicator

Programming Languages: SAS 9.2, C, SQL, HTML, Object Oriented Programming(OOP)

PROFESSIONAL EXPERIENCE

Confidential, Philadelphia, PA

Clinical SAS Programmer

Responsibilities:

• Program, analyze and evaluate Phase II-III of Clinical Trial data using SAS.
• Developed Analysis Datasets following the ADaM Implementation guide and Specifications.
• Worked on Statistical Analysis and generated Reports, Listings and Graphs using BASE SAS and SAS procedures such as PROC SUMMARY, PROC TABULATE, PROC FREQ and ODS procedure.
• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.
• Generated SDTM and ADaM Datasets using Implementation guide and Specifications.
• Created project specific macros and formats and used the existing macro libraries to ensure consistency and integrity.
• Prepared/reviewedprotocol documents, CRF, annotated CRF, and statistical analysis plan(SAP) for clinical trials.
• Worked with different CDISC data models such as SDTM, ADaMand Define.xml
• Provided SAS programming support to Statisticians and Data Managers to develop Clinical Reports.
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Established and maintained sound working relationship and effective communication.

ENVIRONMENT: SAS 9.1/9.2, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/MACRO,Windows XP, UNIX

Confidential, Buffalo, NY

Clinical SAS programmer

Responsibilities:

• Worked on Various Phases (I - III) of Clinical Trial Data
• Performed the Validations of Datasets, and TLGs as per the program requirement and Specifications.
• Worked with Statisticians on data integration for safety tables.
• Integrated data from multiple studies for ISS and ISE.
• Prepared specifications and programming of mapping raw datasets to CDISC SDTM Standards.
• Performed SDTM Validation Checks.
• Generated SDTM and ADAM Datasets using CDISC Standards.
• Involved in generating various e-submission deliverables for the FDA.
• In-depth knowledge of statistical analysis techniques for clinical studies.
• Used standard and global macros for specific needs to improve the quality of work.
• QC SAS Programs to generate appropriate Tables, Listings and reports to support data cleaning activities according to data manager requirements.
• Created SAS output RTF and PDF files using Output Delivery System (ODS) Facility.
• Established and maintained libraries of fully documented and validated SAS programs/ macros / procedures used.
• Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.

ENVIRONMENT: SAS 8.1/9.1/9.2,SAS/BASE, SAS/STAT, SAS/GRAPH, Oracle Clinical, Windows XP and UNIX

Confidential, Wilmington, NC

Clinical SAS programmer

Responsibilities:

• Developed new or modified SAS programs to load data from the source and create study specific datasets.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL
• Generated Reports based on the requirements using PROC REPORT, PROC TABULATE, PROC PRINTandDATA NULL
• Validated SAS data sets using SAS procedures like PROC MEANS, PROC FREQ and PROC UNIVARIATE
• Developed SDTM data mapping and created SDTM domains such as AE, LB, DM, SE, EG, EX, IE etc. and their SUPPQUAL datasets.
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Extensively used SAS Macro options such as MPRINT, MLOGIC and SYMBOLGEN to test and debug existing macro programs.
• Used the CDISC-SDTM to CRT-DDS transformation to transform SDTM domains into a define.xml file.
• Reviewed and provided feedback for Data Integrity Plans.

ENVIRONMENT: SAS 8.1/9.1/9.2, SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, Windows XP

Confidential

SAS Programmer

Responsibilities:

• Provided SAS Programming using SAS/Base, SAS/STAT, SAS/Macros and SAS/Report.
• Worked in II and III Phases of clinical Data.
• Worked extensively with SAS Functions/Macros/Procedures.
• Created the designated Tables, Figures, and Listings according to the Statistical Analysis Plan (SAP) and following the guidelines of the Programming Manager.
• Validated the analysis datasets, TLG’s by Independent programming.
• Involved in generating Efficacy and Safety tables as per the requirements of the Statistician and SAP.
• Created ad-hoc reports as per requirement.
• Used SAS/ODS for generating reports.
• Knowledge of CRF-Annotation with respect to various database designs.
• Performed verification of SAS-generated outputs (tables, listings and graphs) via independent programming.
• Carried out all activities according to SOPs. Ensure adherence to programming guidelines.

ENVIRONMENT: SAS 8.1/9.1/9.2, SAS/BASE, SAS/STAT, SAS/ODS, SAS/SQL, SAS/GRAPH, Windows XP