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Sr. Sas Programmer Resume Profile

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Oncology, NJ

Professional Summary

  • SAS Certified Statistical Programming professional with 14 years of experience in pharmaceutical industry.
  • Extensive working experience in clinical trial and clinical practice, solid knowledge of clinical procedure, clinical diagnostic method, medical and drug terminology, laboratory techniques, clinical lab results and analysis of PK Data.
  • Developed and validated program for derived analysis data sets, safety and efficacy reports, listings and figures, and ad-hoc requests. Developed various MACROs for summary reports, listings and figures.
  • Extensive experience on early development Phase I studies.
  • Working knowledge of CRT Dataset creation from clinical trial data and MedDRA for regulatory submissions.
  • Working Knowledge of Clinical Data Interchange Standards Consortium CDISC relating to data standards including Study Data Tabulation Model SDTM , Analysis Dataset Models ADaM and Case Report Tabulation Data Definition Specification Define.xml .
  • Worked with FDA regulations and ICH guidelines, IND and NDA submission.
  • Extensive experience as study lead programmer in multiple therapeutic areas including Oncology, Infectious disease, Central nervous system, cardiovascular disorders.
  • Permanent Resident Green Card .

WORK EXPERIENCE

Sr. SAS Programmer

Confidential

  • Responsible for the development, review, validation, and execution of SAS programs to generate standard SDTM and ADaM and non-standards custom study specific datasets to be included in reports for submission to regulatory agencies, publications, and other communications.
  • PK/PD Dataset Production reviewed specifications for PK/PD data file developed and performed QC on PK/PD data file produced and performed QC on draft tables produced tables delivered pre-specified, QC datasets to the PK clinical group for further analysis produced tables, graphs and analyses for all reporting events for all data including PK concentration parameters for a study.
  • Provided SAS programming and Analysis support for early development group, phase 1 clinical drug trial and biomarker studies.
  • Maintained standard macros for various indications within the compound.
  • Produced safety and efficacy reports - tables, graphs, listing.
  • Conducted various statistical analyses, by PROC GPLOT, PROC MIXED and PROC LIFETEST.
  • Provided and maintain project plan for all projects/study including milestones, tasks, and coordination of programming activities.
  • Worked with our support staff and take the role as study Programming Lead.

Sr. Statistical Programmer

  • Generated draft and final sets of summary data tables and analyses as part of clinical study reports and ISS/ISE documents for regulatory submission.
  • Developed utility SAS macros for use in project programs.
  • Wrote project-specific programming code to produce summary data tables and analyses, as specified in statistical analysis plans.
  • Produce tables and analyses for all reporting events for all data including PK concentration parameters .
  • Validated SAS macros and derived data sets developed by other programmers.
  • Created Submission Datasets in CDISC SDTM and Analysis Datasets in CDISC ADaM standards.

Sr. SAS Programmer

  • Extracted, manipulated, summarized, analyzed and presented data using SAS procedures
  • Developed, tested, and validated programs to produce figures, tables, listings, data mappings, and extracts
  • Prepared SDTM Version-3. 1 and AdaM-Version 2.0 data sets as per CDISC standards..
  • Developed programs for creating new variables and Transforming horizontal CRF data into Vertical dataset according to CDISC guidelines.
  • Participated in writing of clinical trial reports, analyzing, and presenting trial results
  • Created Physical Data Model Documents
  • Performed QC of published tables, SAS datasets, and algorithms produced QC documentation
  • Provided input to or review interim analyses plan and produced tables, listings, figures, and datasets for interim analysis
  • PK/PD Dataset Production reviewed specifications for PK/PD data file developed and performed QC on PK/PD data file produced and performed QC on draft tables produced tables delivered pre-specified, QC datasets to the PK clinical group for further analysis produced tables and analyses for all reporting events for all data including PK concentration parameters for a study
  • Developed SAS macros for data cleaning and reporting
  • Maintained standard macros for various indications within the compound.

Sr. SAS Programmer

  • Develop SAS programs to produce tabulations, graphics, listings and datasets of clinical trial data to meet customer requirements
  • Perform QC on tabulations, graphs, listings and datasets created by others
  • Use SAS BASE, Macros, PROC REPORT, PROC SQL, PROC GLM programming to support Phase II/III trials
  • Worked on CDISC standards and various models, Analysis Dataset Model ADAM , Operational Data Model ODM and Study Data Tabulation Model SDTM
  • Develop and perform QC on PK/PD data file produce and perform QC on draft tables
  • Develop technical documents for Regulatory and Clinical/Commercial Support
  • Supported NDA, ISS, ISE, IND reports.
  • Modified existing SAS programs and created new programs using SAS macro variables to improve ease and speed of modifications as well as consistency results.

Sr. SAS Programmer

  • Manipulating, summarizing, analyzing and presenting data using SAS procedures Develop SAS programs to create and validate figures, tables, listings, data mappings, and extracts.
  • Participated in writing of clinical trial reports phase I-II , analyzing, and presenting trial
  • Created Physical Data Model Documents.
  • Perform QC of published tables, SAS datasets, and algorithms Produce QC documentation
  • Provide input to or review interim analyses plan and Produce tables, listings, figures, and
  • datasets for interim analysis.
  • Perform PK merge and PK/PD Dataset Production Review specifications for PK/PD data file
  • Produce tables and analyses for all reporting events for all data including PK concentration
  • parameters .
  • One of the main programmers for 2 NDA submissions.
  • Developed and maintained SAS programming macros that facilitated programming team.

Sr. SAS Programmer

  • Developed SAS programs to produce tabulations, graphics, listings and datasets of clinical trial data to meet customer requirements
  • Performed QC on tabulations, graphs, listings and datasets created by others
  • Worked on CDISC standards and various models, Analysis Dataset Model ADAM , Operational Data Model ODM and Study Data Tabulation Model SDTM
  • Created CDISC SDTM domain data sets from existing clinical trial data to provide Case Report Tabulation CRT data to a regulatory agency, such as the FDA and ADaM for describing the full protocol of a clinical trial.
  • Created ISS and Analysis datasets
  • Wrote some common macros that were useful across multiple studies
  • Developed routine SAS Macros to create tables, graphs and listings for inclusion in clinical study reports.
  • Performed data mapping of raw datasets according to the company and CDISC SDTM standards in compliance with the mapping programs and specifications
  • Reviewed protocols and CRFs to ensure data were collected in a consistent manner across the drug database
  • Wrote edit check programs in SAS following the Data Cleaning Plan DCP specifications
  • Reviewed large macro codes for running the programs
  • Worked on Kaplan-Meier macro to generate the graphs as per the requirements for FDA submission
  • Worked with Bio-statistician to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM and mixed models
  • Optimized performance using Data Validation and Data Cleaning on Clinical Trials data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVERIATE Endpoints parameters such as AUC, CMAX, TMAX for insulin and glucose using PK and PD profiles data
  • Worked as part of a team to complete the reporting of clinical trial data in an efficient manner for inclusion in statistical or other reports
  • Liaised with functional groups and customers to understand and help define requirements
  • Reviewed and contributed to relevant documentation
  • Delivered assigned tasks on time, efficiently and to required quality
  • Provided effective and timely communication with line manager and relevant project personnel
  • Understand the drug development process, familiarity with SOPs and guidance documents

Clinical SAS Programmer

  • Wrote SAS programs for analysis in UNIX and PC environment
  • Generated tables, listings, figures using PROC TABULATE, SUMMARY, REPORT, GPLOT, GCHART, DATA NULL , ODS, etc, to evaluate safety, efficacy, tolerability and pharmacodynamic effects Phase I-III clinical trials in CNS, CV, respiratory disorder, gastrointestinal, disorder, diabetes, infection, arthritis, generic drug, imaging diagnostic agent, etc.
  • CDISC STDM implementation in submission dataset
  • Validation and review of other Programs
  • Responsible for study CRF annotation using STDM variables and SDTM Data specification review
  • Generated CRF tracking and other reports
  • Created data files for PK analysis
  • Conducted multiple pooled analyses including ISS that covered various of phases and designs of imaging agent and investigational medication studies
  • Transformed Data and Creating Analysis Data sets referring to the specifications provided according to the CDISC standards
  • Produced customized and annotated SAS graphs error bar chart, box plot, error bar chart, box plot, error bar plot, survival curve, etc.
  • Created Modular code with Macros, wrote Macros with conditional logic, wrote Data-Driven Programs with CALL SYMPUT
  • Tested Categorical Data with PROC FREQ, Producing Statistics with PROC MEANS
  • Wrote edit checks from the Data Cleaning Plan DCP specifications
  • Checked values of Numeric Variables, Checked for Missing Values, Looked for n Observations per subject, verified double entry and used SQL for Data Cleaning
  • Extracted Data from Oracle database using SAS/ACCESS, E-review, PROC SQL
  • Wrote Delimited and HTML files using ODS
  • Used PROC TTEST, PROC UNIVARIATE, PROC CHART, PROC GLM, PROC ANOVA for Relationship with Continuous dependent variables
  • Converted SAS datasets to Xport format
  • Provided SAS training to Oracle Clinical programmers
  • Set-up data extracts in Oracle Clinical

Senior SAS Programmer,

  • Provided SAS/SQL programming expertise in the production of Analyses, Tabulations, Graphics and Listings from various data
  • Used SQL for data analyses and Statistical Reporting and to create, populate and delete tables
  • Duties included SAS Programming on UNIX Enterprise Server C-Shell and Windows NT environments
  • Tested a series of SAS programs to generate PDF, HTML, RTF and ASCII Listings using SAS
  • Used SAS BASE, Macros, PROC REPORT, PROC SQL, PROC GLM programming to support Phase III trials
  • Transferred data between databases using import/export facility in SAS and FTP
  • Created SAS Macros to consolidate and streamline table writing routines
  • Produced report-producing from Datamarts/data Warehouses using VBA
  • Wrote stored procedures using MS SQL
  • Converted SPSS system files to SAS
  • Uploaded SAS transport files onto UNIX
  • Converted Excel applications to HTML, utilizing ODS
  • Assisted in the integration of data from remote entry sites

COMPUTER SKILLS

Operating

  • Systems : Windows NT/2000/XP,VAX/VMS,UNIX,MS-DOS.
  • Languages : Java, C/C ,Visual Basic, Java Beans,HTML,FORTRAN,Open GL, SQL, XML, ,
  • Korn Shell Script.
  • Software :SAS/BASE,SAS/STAT,SAS/GRAPH,SAS/ACCESS,SAS/CONNECT,SAS/ASSIST,
  • S-Plus, MS Access 2000,Excel,MS-SQL, PGP, Forte,Power Point,MathCAD,
  • Photoshop, Illustrator, Visual Basic, IPRO,Doculex.
  • PROC SAS :PROC PRINT,PROC IMPORT,PORC CONTENTS,PROC SORT,PROC FORMAT,
  • PROC MEANS,PORC FREQ,PROC TABULATE,PROC REPORT,PROC TRANSPOSE,
  • PROC UNIVARIATE,PROC CORR,PROC REG,PROC ANOVA,PROC GLM,PROC
  • EXPORT, PROC APPEND, PROC CHART, PROC CONTENTS, PROC CORR, PROC
  • DATASETS, PROC FACTOR, PROC FORMAT, PROC LOGISTIC, PROC
  • NPARWAY, PROC RANK, PROC PLOT, PROC RSQUARE, PROC STEPWISE,
  • PROC SUMMARY, PROC TTEST, PROC MIXED.
  • Oracle Clinical: Data Management, Data Validation, Statistical Report Generation, Program
  • Validation.
  • IReview :Familiar to opening objects, selecting patients using report browser,
  • scheduling and reviewing output using the data browser and notes browser,
  • using the patient profile browser, using the graph browser using the cross tab
  • browser, using the SAS browser.
  • Familiar to : Cognos Powerplay/Impromptu, AS 400, Mainframe, Oracle 10g, PL/SQL, DB2,
  • JCL, Bloomberg Terminal, Matrix Manipulation, Relational database design.
  • Health Care : ICD-9 / ICD-10 Diagnosis Codes ICD-9 Surgical Procedures
  • CPT, HCPCS Codes Pharmacy-Specific codes Data Forms, Layouts and
  • Files HCFA-1500, Pharmacy, UB-92

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