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Sr. Sas Programmer Resume Profile

Florham, ParK

PROFESSIONAL SUMMARY

  • Sr. SAS programmer with over 6 years of experience in SAS programming and experience in analysis, design, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries.
  • Knowledge of the drug development process with strong experience of analyzing and reporting in phase I, II, III of clinical trial data.
  • Experienced in CDISC SDTM mapping from raw datasets, SDTM I.G and annotated eCRF.
  • Involved in creation and validation for SDTM and ADaM data sets, tables and listings.
  • Developed general-purpose and ad-hoc SAS programs/macros for the extraction, manipulation, analysis, presentation and validation.
  • Extensive experience in using various SAS tools like SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACCESS, SAS/CONNECT, and SAS/SQL.
  • Provided programming expertise in generating Tables, Listing and Figures TLF's as per the mock shells and SAP for ISS and ISE.
  • Knowledge of CRT Dataset Creation, CDISC for regulatory submissions.
  • Experienced in OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml.
  • Knowledge of FDA regulations, ICH Guidelines and GCP requirements.
  • Very good experience in analyzing Case Report Forms CRF data, Clinical Trials, Clinical Data Analysis, Clinical Data migration, Validations and Documentation.
  • Highly adaptive to a fast paced team environment and with a proven ability to work in a team environment and individually. Have excellent communication and written skills.

TECHNICAL SKILLS:

SAS TOOLS

SAS9.1.3,SAS9.2,SAS/BASE,SAS/MACROS,SAS/SQL,SAS/STAT,SAS/GRAPH, SAS/ODS, SAS/ACCESS.

SAS PROCEDURES

CONTENTS, PRINT, SORT, IMPORT, EXPORT, DBLOAD,

DATASETS, TRANSPOSE, PRINTTO, FORMAT, SQL,REPORT, TABULATE, MEANS, FREQ, SUMMARY, ANOVA,CHART, PLOT, GPLOT, GCHART

OPERATING SYSTEMS

UNIX, WINDOWS 98/XP/2000/NT

DATABASES

ORACLE 8/8i/9i, ORACLE CLINICAL

LANGUAGES

SAS 8/9, SAS Enterprise Guide, C, PL/SQL

OFFICE TOOLS

MS-OFFICE, Word, Excel, PowerPoint, HTML

PROFESSIONAL EXPERIENCE:

Confidential

Role: Sr. SAS Programmer

Responsibilities:

  • Worked extensively on CDISC SDTM domains and generated the xpt files.
  • Created ADaM datasets using CDISC standards.
  • Well-versed in using OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml.
  • Reviewed Protocol, DST Data Specifications Table , DVM Data Validation Manual , Edit Check document, Quality Plan for TLFs, SAP, SOPs, and eCRF layout and eCRF completion Guidelines.
  • Annotated eCRF according to SDTM standards.
  • Developed DDT's Data Definition Tables for SDTM datasets.
  • Worked with Data cleaning and data validation on the work developed by other programmers.
  • Developed SAS programs for Edit Checks, also validated listings, summary tables for drug study.
  • Performed quality control checks on program code and outputs produced by other team members.
  • Created macros to ensure the variables are as per CDISC guidelines.
  • Extensively involved in creation and validation of Tables, Listings and Graphs TLG and Ad-hoc reports.
  • Extensively used PROC SQL, PROC TRANSPOSE, PROC MEANS, PROC UNIVARIATE, PROC FREQ, PROC PRINT, and PROC COMPARE for checking the assumptions and statistical analysis.
  • Generated programs in MACROS to generate graphs, listings, quality tables for clinical study reports and regulatory submissions.
  • Customized existing SAS programs and created new programs using SAS MACRO facility to improve simplicity and pace of modification as well as reliable solutions.
  • Developed programs for safety and efficacy tables such as Adverse events, Labs, Dose Exposure tables, vitals, ECG, Demographics, Disposition and baseline characteristic tables.
  • Handled Dropouts and Missing Data by using Last Observation Carried Forward LOCF .
  • Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML.
  • Created formats for the coded data and used PROC SQL for data validations.
  • Worked with ARRAYS, first. Variable and Last. Variable.

Confidential

Role: Sr. SAS Programmer

Client:Novartis

Responsibilities:

  • Involved in creation and validation of data sets SDTM and ADM .
  • Developed specifications for database in CDISC format and involved in programming datasets in CDISC format STDM model 3.1 .
  • Involved in running and interpreting WEBSDM checks for derived data sets.
  • Involved in running and interpreting OPEN CDISC VALIDATOR for derived sets.
  • Importing the data in to SAS from Excel Spreadsheet using PROC IMPORT.
  • Program, test, and document databases in accordance with programming standards and validation procedures.
  • Validated derived datasets, tables, listings and graphs as per specifications and mockups in SAP
  • Generated various Efficacy and Safety Listings, Tables and graphs for several studies
  • Used procedures such as Freq, Means, Univariate, GLM, Mixed, T-test, Report, and Transpose to prepare various statistical results in RTF formats
  • Involved in creating the data definition table and SAS transport files for submission as a part of the final report to the FDA
  • Producing Top line efficacy results and creating analysis dataset for these efficacy results as per the specifications of client
  • Created ad-hoc reports using SAS

Confidential

Role: Sr. SAS Programmer

Responsibilities:

  • Developed standard agreement documents to facilitate data transfers from External vendors.
  • Created SDTM Domains, ADaM datasets, TLF's as primary programmer and validated as secondary programmer.
  • Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
  • Used Data Null technique for producing customized reports.
  • Served on various internal committees to develop macros and standardize processes.
  • Extensively used SAS procedures like PROC FREQ, PROC MEANS, PROC REG, PROC CORR, PROC TABULATE and PROC REPORT.
  • Generated statistical analysis, tables, listings and graphs for Phase I-II clinical studies.
  • Worked with various SAS modules such as SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS/ MACROS to generate statistical deliverables.
  • Developed ad-hoc reports as per the Biostatistician and client requests.
  • Documented programs while being compliant with ICH-GCP guidelines and SOPs.
  • Performed data checks as needed, to ensure integrity and correctness of data displays.
  • Created project specific macros and formats to ensure consistency and integrity of data.

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