SUMMARY

• Certified Base SAS programmer with 5+ years of experience as clinical SAS Programmer.
• Proficient with experience in various phases of clinical trials and strong understanding of study design protocol, Case report form (CRF), Statistical analysis plan (SAP) and data dictionaries (MedDRA, WHO - DRUG).
• Very good Knowledge of CDISC-SDTM, ADaM standards for regulatory submissions, FDA and ICH guidelines.
• Experienced in creating and validating SDTM, ADaM datasets as per CDISC standards to support clinical trial analysis and reporting.
• Excellent work experience in generating and validating reports, Tables, Listings, and Graphs according to Statistical Analysis Plan and departmental guidelines.
• Knowledge in preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports for FDA submission.
• Proficient in writing macros and in using stored and compiled macros to create SAS data sets, Tables, Listings and Graphs from procedure Output and automatically send to various destinations (including HTML, RTF, PDF) by using SAS ODS facility.
• Experienced in working with Data Management in creating various reports based on data integration and query generation.
• Extensive knowledge and experienced in understanding the existing macro programs and modify them as per the study requirement.
• Very good experience in working on ADHOC reports under tight timelines.
• Proven ability to manage multiple assignments and handle changing priorities in a fast-paced environment.
• Effective team player with strong communication & interpersonal skills.

TECHNICAL SKILLS

SAS Tools: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/ODS

Office Tools: MS-word, MS-excel, MS-Power point

CDISC Standards: SDTM (v 3.1.1 - v 3.1.3), ADaM (v 1.0), Open CDISC Validator

Operating System: Windows 2010/2008/2007/ XP

Languages: SQL, SAS, R

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential, NJ

Responsibilities:

• Worked with data management in reviewing protocol, CRF and generated edit check listings.
• Generated data review listings for Quality and medical monitors.
• Performed data cleaning by analyzing and eliminating duplicate and inaccurate data using PROC FREQ, PROC UNIVARIATE, and macros in SAS.
• Involved in annotating case report form (CRF) while creating SDTM specifications CDISC-SDTM Meta data.
• Generated and validated SDTM and ADaM datasets as per CDISC standards.
• Involved in developing, testing, tables, listings and graphs programs according to study specific mock shells and SAP.
• Developed and used SAS Macros programs to generate tables and listings.
• Extensively used SAS reporting procedures like PROC REPORT, graphic procedures like PROC GPLOT and PROC LIFETEST for survival analysis.
• Generated ADHOC reports using the SAS procedures, ODS pass through facility and PROC TEMPLATE to generate output in different formats like HTML, PDF and RTF.
• Prepared data for FDA submission as per CDISC submission standards and guidelines.
• Used PROC COMPARE to conduct quality control checks on datasets, tables and listing.

Clinical SAS Programmer

Confidential -Deerfield, IL

Responsibilities:

• Worked as a SAS programmer in various phases of clinical trial data in CNS therapeutic area.
• Worked closely with biostastician to support the analysis in various phases of clinical trials.
• Developed SDTM data mapping and created SDTM datasets in CDISC standards.
• Developed and designed Statistical analysis data set ADaM in CDISC standards.
• Generated outputs such as tables, listings and graphs as per Specifications in Reporting and Analysis document.
• Extensively involved in the generation of ISS and ISE analysis as per Statistical Analysis Plan (SAP).
• Developed numerous ad-hoc SAS programs to create summaries and listings.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time.
• Reviewed case report forms (CRF) to ensure their design meets the protocol criteria and contains all data required to support a high-quality database and planned analysis.
• Gained an understanding of pertinent regulatory processes and forms for Investigational New Drug applications INDs and New Drug Applications NDAs .
• Worked with clinical teams to resolve issues regarding the interpretation, evaluation, and reporting of clinical data.
• Attended weekly meetings with Manager and Biostatistician to discuss about work progress and queries regarding project.

Environment: SAS 9.1/9.2, Base SAS, SAS/Macro, SAS/Sql, SAS/Connect, SAS/Access, SAS/Graph, SAS/Stat, Excel, Word, Windows, UNIX

Confidential, CA

SAS Analyst

Responsibilities:

• Involved in phase I and phase II clinical trial data.
• Involved in SAS programming for Clinical trials in Cardiovascular and infectious deceases therapeutic area and e-submissions to FDA.
• Reviewed protocol and Case Report Forms to identify irregular data entry errors of clinical trial data and acquired knowledge.
• Created safety and efficacy customized reports for FDA regulatory submissions.
• Involved in Mapping and Integrating study data to a CDISC-compliant Proprietary analysis data system.
• Involved in writing SAS program code using SAS/BASE, SAS/MACROS, SAS/STAT to produce analysis datasets.
• Developed specifications for database in CDISC format and involved in programming datasets in CDISC format (STDM model 3.1) and managed CDISC database for several studies.
• Participated in preparing reports for regulatory submissions as well as ISS and ISE for FDA submissions using SAS.
• Validated all the tables and listings using validation rules defined in programming SOP’s.
• Participated in weekly meetings with team lead to discuss about work progress and queries regarding project.

Environment: SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/MACROS, Windows, Excel.