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Sas Clinil Programmer Resume

CA

OBJECTIVE:

TO Obtain a challenging position of SAS Programmer or DATA Analysist where I can put in USA the best of my knowledge and experience of SAS Programming and other analytics tools for the growth of the organization.

SUMMARY:

  • SAS Programmer/Analyst with 8+ years of Programming, Statistical Analysis and reporting experience in various SAS tools emphasizing on analysis, design, development, testing, and implementation of various projects.
  • SAS Programming experience in Statistical analysis, validation and Statistical report generation of Clinical trial data
  • Base SAS, SAS/Stat, SAS/Graph, SAS/Macro, and SAS/ODS, SAS/Access, and SAS/SQL under Windows environment. Thorough understanding of SAS Enterprise Business Intelligence Toolset.
  • Efficient in scheduling different processes using SAS DI studio.
  • Good Knowledge of Phase I, II, III and IV of Clinical trials in various therapeutic areas like Anti - Psychotic, Dermatology, Immunology, Oncology, Muscular Skeletal.
  • Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of Clinical trials and CRF forms.
  • Experience in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL.
  • Implemented CDISC standards manage CDISC database for several studies by Strong understanding of CDISC SDTM models and experience in converting data to CDISC SDTM Standards.
  • Collaborated with Clinical Data Management to annotate CRFs with standardized variables and formats using PROC DATASETS, PROC FORMATS.
  • Able to deliver quality outputs under stringent timelines.
  • Reconciliation of external data with CRF data and reporting the issues that were not reconciled either in CRF data or external file to DM and getting the issues resolved.
  • Checking the data issues thoroughly between the data transfers received from CDM team. Also, the subsequent transfers were compared with the earlier ones to check the data consistency and the variable attributes and to point out the resolution of already identified issues with earlier transfers.
  • Wrote specifications for SDTM and ADaM datasets.
  • Working experience in CDISC models SDTM and ADaM datasets creation and validation of produced datasets and DEFINE.XML using standard guidelines.
  • Generated the define.xml and data Reviewer's guide (Metadata for submissions)
  • Worked on open confidnetial validator and resolving those errors.
  • Created and validated Table, Listings, and Figures by using ADaM datasets.
  • High proficiency in creating output files in a variety of formats including EXCEL, RTF, HTML and PDF etc. using SAS /ODS and SAS /EXPORT for reporting and presentation.
  • Responsible for developing and modifying reports based on Statistical Analysis Plan, or creating Ad Hoc reports by using REPORT, and SUMMARY and provided descriptive statistics using MEANS, FREQ.
  • Worked on Data Management SAS DATA step processing, PROC SQL for data extraction, write datasets, Report and use of PROC REPORT, DATA NULL, SAS Macro processing.
  • Proficient in Debugging and Validation skills.
  • Extensive experience and skill in modifying existing SAS programs.
  • Extensive experience in SAS products including BASE SAS, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS.
  • Solid working experience in Data Manipulations using SAS procedures such as Array, Do Loop, PROC SQL, MERGE, PROC SORT, PROC TRANSPOSE, etc.
  • Well versed with Clinical Trial processes such as Randomization Process, Trial execution, Statistical Analysis, Data capture, Data cleaning, Data Management and Reporting.
  • Developed tables, listings and figures, for Clinical studies and prepared regulatory documents for FDA submissions.
  • Created SAS datasets (. xpt files) for electronic submission as per client requirement.
  • Work assignment among the team and coordinate with study statistician and team to get work done with in timelines with quality deliverables.
  • Ability to handle multiple tasks and work independently as well as in a team.
  • Working knowledge of FDA regulations, ICH Guidelines and GCP requirements .
  • Strong expertise in analysis, design, development, testing, and implementation of Business Analytics using SAS software. Solid understanding of data cleansing, data management, and data processing techniques like merging, concatenating, interleaving, appending of SAS datasets and data validation.
  • Thorough experience in extracting data from various disparate data sources like (xls, csv, txt) files, SQL Server etc.
  • Ability to analyze & process data using various SAS procedures such as utility procedures, report procedures, statistical procedures.
  • Well versed in the platform for SAS Business Analytics and SAS BI dashboards.
  • Expertise in writing complex SQL queries, connecting multiple sources like Oracle, DB2 via SAS.
  • Followed System Development Life Cycle (SDLC) methodology for the design, development, implementation, and testing of various SAS modules
  • Process excellent knowledge of statistical software like BASE SAS, ADVANCE SAS< SAS MACROS, SAS SQL, SAS STAT AND SAS GRAPH.
  • Good programming experience with various SAS procedure, SAS Functions, Data manipulation and statistical techniques.
  • Involved in Data Cleaning, Data Manipulation, and Data Validation.
  • Comprehensively prepared reports using SAS report generating procedures like PROC PRINT, PROC FREQ, PROC MEANS and PROC TRANSPORE, PROC IMPORT, PROC EXPORT.
  • Considerable experience in Data Merging, Data Sub setting with the use of, MERGE and SET statements.

TECHNICAL SKILLS:

SAS: Base SAS, Data Step, SAS procedures, Formats, Informants, Macros, Data Null Reports, SAS Functions, SAS ODS, Arrays, SAS Procedures, SAS testing, Append, Compare, Chart, Contents, Datasets, Copy, Export, Format, Freq, Import, Means, Print, SQL, Sort, Summary, Tabulate, Transpose and Univariate.

Databases: MS-Excel and SQL Server.

SAS Products: Base SAS, SAS/Access, SAS/Connect, SAS/Share, SAS/Graph, SAS-ODS SAS Add-in for MS-office, SAS Enterprise Guide, SAS Enterprise Business Intelligence, SAS Information Map Studio, SAS Data Integration Studio, SAS OLAP, SAS BI Dashboard.

Operating Systems: Windows XP, 2003, Vista and UNIX.

Programming Languages: SAS and SQL.

PROFESSIONAL EXPERIENCE:

SAS Clinical Programmer

Confidential, CA

Responsibilities:

  • Excellent knowledge in analyzing and reporting data for Phase I, Phase II, Phase III and Phase IV clinical trials.
  • Experience in Clinical Trials, Clinical Data Analysis, and Generating Statistical Analysis datasets, Tables, Listings, Graphs and Validations.
  • Experience in both Pharmaceutical/CRO in handling Phase I - IV Clinical trials data.
  • Worked on Clinical trials data in different therapeutic areas viz., Oncology, Cardiology, Pain Management, Endocrinology, and Central Nervous System etc.
  • Hands on experience in coordinating clinical trial data, generating reports and tables along with graphs using SAS software.
  • Great knowledge of Clinical Data Interchange Standards Consortium (CDISC) process related to data standards including Study Data Tabulation Model (SDTM) and Analysis Dataset Models (ADaM)
  • Proficient in handling the clinical trial data like demographic data (DM), concomitant medications (CM), adverse events (AE), laboratory data (LAB DATA), subject visits (SV) and vital signs (VS)
  • Good knowledge of developing Ad Hoc reports as per the requirement of the medical writer/FDA
  • Expertise in Dataset Creation and Table/Listings Programming for integrated Summaries of Efficacy (ISE) and Safety (ISS)
  • High proficiency in understanding clinical trials study designs and protocol along with case report form (CRF/eCRF), annotated case report forms and company Standard Operating Procedures (SOP)
  • Migration of users, data and corresponding Metadata from SAS 9.4 stand alone to 9.4 multi-tier Grid.
  • Excellent knowledge in SAS Programming application like Base /SAS, SAS /Macros, SAS/SQL, SASSPDS in both Windows and Linux Environment.

SAS Clinical Programmer

Confidential

Responsibilities:

  • Programming Experience with SAS report procedures like PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC PRINT, and PROC SQL.
  • Experience in Design and building of SAS/PLSQL Programs to analyze and coordinating clinical trial data for generating Reports, Files, Tables and Listing the Healthcare data to send communication to regulatory authorities.
  • Excellent knowledge of SAS ETL
  • Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spreadsheet, Microsoft Excel and Access tables.
  • Involved in SAS edit check programming for Data management.
  • Excellent experience with export SAS Results to different format, such as XML, Excel using SAS/Export, SAS/ODS for reporting and presentation
  • Understand SAS to evaluate a wide range of data types and to perform analyses according to analysis plans
  • Knowledge of executing the test procedures and developing new computer programs.

Environment: SAS V9.3/9.4 on Unix and Windows platform, SAS EG, SAS OLAP Cube Studio, SASWebReport, SAS/ACCESS, SAS/CONNECT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ETL, Excel, Access, E-clinical Works.

SAS Programmer:

Confidential

Responsibilities:

  • Assisted and developed SAS programming and analysis support for Phase clinical
  • Used Dynamic Data Exchange (DDE) for importing and exporting of data from and into SAS, MS Access and Excel.
  • Performed Data Cleaning and Validation using SAS data step and SAS procedures.
  • Produced summaries and statistics using PROC MEANS, PROC SUMMARY, PROC FREQ, PROC ANNOVA and PROC UNIVARIATE.
  • Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
  • Worked closely with Manager, Statistician in analyzing datasets and studying populations in electronic databases.
  • Assisted in the development of Statistical Analysis Plans, reviewing study protocols and reports.
  • Provided outputs for the Clinical Study Report (CSR).
  • Analyzed Adverse Event (AE) data using PROC FREQ.
  • Created complex and reusable Macros and extensively used existing Macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
  • Extensively used Data Null and SAS procedures such as Print, Report, Tabulate, Freq, Means, Summary and Transpose for producing ad-hoc and customized reports and external files.
  • Created CRTs with datasets in Transport File Formats and Data Definition Tables for NDA submissions to FDA.
  • Worked with CDISC data models including SDTM, ADAM.
  • Develop new or modify SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
  • Cross-Validated SAS programs authored by other SAS programmer as a part of QA (Quality Assurance) analysis.
  • Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.

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

Confidential

SAS Programmer

Responsibilities:

  • Worked on Phase I and II Clinical Trials.
  • Used SAS Base procedures like PROC FREQ and PROC UNIVARIATE to generate Safety tables (Adverse Events, Demographic listing) and quality tables for clinical study reports and regulatory submissions.
  • Developed SAS macros for data cleaning and Reporting.
  • Generated statistical analysis files, tables, listings, and graphs for clinical trial studies
  • Involved in delivering output using SAS/ODS .
  • Extracted data from databases and flat files.
  • Created html and PDF output files by using SAS ODS AND PROC REPORT, PROC TABULATE, DATA NULL AND PROC SQL to customize the reports
  • Enhanced reports using labels, SAS formats, user - defined formats, titles, footnotes and SAS system reporting options.
  • Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSM, TRUNCOVER, MISSOVER etc.

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

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