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Clinical Trial Programmer Resume

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NJ

SUMMARY

  • SAS programmer wif 7 years of extensive experience, SAS Analyst in Clinical/Pharmaceutical, Medical Technology Industries and Banking for data analysis, coding and implementation in Windows and UNIX environments.
  • Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving Analysis, design, development, testing and validating teh applications.
  • Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS.
  • Proficient in Importing or extracting data using Import techniques to create SAS datasets from various sources like Relational databases by connecting SAS System to database systems, such as Microsoft SQL, Oracle, Excel, flat files, and Exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS .
  • Knowledge of collecting client's requirements and accessing datasets from teh client's data warehouse using Base SAS.
  • Programming experience wif procedures like PROC DATASETS, PROC PRINT, PROC APPEND, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT, PROC FORMAT, and PROC COPY.
  • Hands on experience in data management like Merging, concatenating, interleaving SAS datasets using MERGE and SET statements in DATA step and using PROC SQL.
  • Creating new SAS Programs using SAS MACRO to improve ease and speed of modifications as well as consistency of results.
  • Expertise in using SAS report generating procedures like PROC REPORT, PROC SQL, PROC TABULATE, PROC TRANSPOSE, PROC SUMMARY and Optimized performance using Data Validation and Cleaning on Clinical Trial data using statistical procedures like PROC FREQ, PROC ANOVA, PROC MEANS, and PROC UNIVARIATE.
  • Proficient in CDISC standards and transforming raw data to create datasets following these standards
  • Proficient in performing QC on programs by developing Quality Control (QC) procedures
  • Knowledge of using SAS 9.2/Enterprise Guide in Data Analysis, understanding of RDBMS (Oracle 8/8i/9i, 10g), PLSQL, Microsoft Excel, PowerPoint. Programming in C and UNIX.
  • Good noledge of Drug Development Process including all clinical trial phases me - IV.
  • Expertise in working wif clinical trial data like demographic, AE, SAE, Lab, Vital Signs and CRF/e-CRF, other essential documents in clinical Research.
  • Experience in Clinical Data Analysis in accordance wif guidelines and providing Clinical Study Reports.
  • Possess strong ability to quickly adapt to new applications and platforms. Experience in interacting wif clients, multiple user groups and managing development teams.
  • Experience in supporting multiple projects under deadlines often wif competing priorities and complexities by applying critical thinking, problem solving, and decision making skills to optimize solutions.

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

OPERATING SYSTEMS: UNIX, LINUX, WINDOWS 98/XP/2000/NT

DATABASES: ORACLE 8/8i/9i, 10g, ORACLE CLINICAL

LANGUAGES: SAS 9.2, SAS Enterprise Guide, C, PL/SQL, PERL

OFFICE TOOLS: MS-OFFICE, Word, Excel, PowerPoint, HTML

PROFESSIONAL EXPERIENCE:

Confidential

Clinical Trial Programmer

Responsibilities:

  • Programming according to specifications, creating analysis datasets, listings, tables and figures for phase III clinical trials wif high quality and wifin milestones
  • Developing and complying wif project/study standards and specifications following internal guidelines.
  • Generated Tables, Listing and Graphs according to teh Statistical Analysis Plan (SAP).
  • Good noledge about URS (user requirement specifications) and immensely involved in creating IVRS (Y1, Y5 & Y7) datasets.
  • Created, validated, documented, and maintained SAS programs to generate analysis datasets, and create safety/efficacy reports including summary tables, listings and graphics for use in regulatory submission.
  • Interacted wif other line functions, such as Biostatistics,Data Management, to ensure a high level of client satisfaction through successful execution
  • Created SDTM annotated CRF documents.
  • Generated Macros for tables and listing and used department Macros to produce reports
  • Performed quality controls (QC) on SAS programs created by fellow programmers.
  • Good Knowledge about CDISC and SDTM standards.
  • Using SAS/ Base and SAS/ Macro facility developed efficient, well-documented and modifiabl SAS code
  • Experience in handling multi-tasks in tight timelines

Environment: SAS/GRAPH, SAS/STAT, SAS/BASE, SAS/MACROS, SAS/SQL, UNIX, SAS9.2, SAS9.3.

Confidential, NJ

Clinical Application Programmer/Analyst

Responsibilities:

  • Performed data analysis on data which was received every three weeks from client side and according to teh requirements generated teh reports and participated in other clinical programming and data management activities
  • Collected requirements from statisticians, prepared requirements document, follow up and developed new macros as per statistician’s request.
  • Attended project team meetings, interacted wif Bio-Statisticians, Data Managers, and Clinical Research Managers.
  • Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) for ISR (Integrated summary report) to compare and to differentiate all other study results and to get conclusion after reviewing teh patient benefit/risk profile of drug.
  • Involved in Extensive coding in base SAS (including Creating Derived Datasets, Tables to produce desired output format, analysis Datasets, Tables, Listing and Graphs.
  • Importing data from different file formats and creating datasets to get desired output using Import procedure.
  • Extracted data from Oracle Clinical database using SQL Pass through facility.
  • Sorting teh data and deleting duplicates by using procedures like PROC SORT in order to produce quality results
  • Creating SAS code to clean teh invalid data using SAS Macros and SQL procedure.
  • Sorting, printing and summarizing teh datasets to modify and combining SAS datasets using sort procedure, set and merge concepts.
  • Developed SAS programs to format teh data for understanding and used various validation techniques such as proc summary, proc means, and other data step techniques.
  • Developed SAS Customized Reports using REPORT, TABULATE procedures and DATA NULL .
  • Developed daily input report, monthly reports using PROC SUMMARY, PROC TABULATE and PROC ANOVA and generated tables and listings using various procedures like PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC UNIVARIATE, and generated graphs using PROC GCHART and PROC GPLOT.
  • Generated teh reports in desired output format (HTML, PDF and RTF format files)for decision making using SAS ODS (OUTPUT DELIVERY SYSTEM)
  • Listings and Reports were created by patient, Treatment group using Proc Report

Environment: Oracle Clinical 4.x, SAS 9X, SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/MACRO, SAS/ACCESS, SAS/ODS, UNIX, MS Access, Excel.

Confidential, NJ

SAS Analyst

Responsibilities:

  • Designing, developing and testing a series of SAS programs for generation of data sets automatically wifout giving parameters from outside.
  • Importing data using SAS/ACCESS in order to extract data from different relational database management (ORACLE and SQL SERVER) systems using SAS.
  • Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort and Update, Formats, Functions and conditional statements.
  • Deriving datasets wif new columns for generating reports
  • Maintained large data sets, combined data from various sources to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
  • Developing macros for automatic running of all programs like Merging, Sorting, Printing of ODS files etc
  • Creating SAS code to clean teh invalid data using SAS Macros and SQL procedure.
  • Sorting, printing and summarizing teh datasets to modify and combining SAS datasets using sort procedure, set and merge concepts.
  • Finding Null Values and deleting teh invalid entries from teh data
  • Deleting Duplicate values form teh data to get accurate results
  • Developing reports using Proc Report, Proc Tabulate, Proc Freq, Proc Means.
  • Generated teh reports in desired output format (HTML, PDF and RTF format files)for decision making using SAS ODS (OUTPUT DELIVERY SYSTEM)
  • Proc report was used to create Listings and Reports by customer, transaction key and account number.

Environment: SAS/BASE 9.1.3, SAS/MACROS, SAS/SQL, SAS/ODS

Confidential, NJ

SAS Programmer

Responsibilities:

  • Generated SAS programs for pre-processing data, data analysis and for generating reports.
  • Imported and Exported data files to and from SAS using Procedures like Import and Export from Excel, various delimited text based data files such as .TXT (tab delimited) and .CSV (comma delimited) files for data analysis.
  • Exporting data files in various desired output formats by using SAS ODS and creating HTML, RTF, and PDF files in teh process of producing reports
  • Used SAS DATA NULL and PUT statements to generate teh customized reports.
  • Generated SAS programs and created macros for Biostatisticians to produce clinical trial deliverables like analysis datasets, tables and figures, patient data listings, and customized reports and validated them using Proc Compare and other procedures
  • Validated SAS programs to create analysis datasets and other output tables by independent SAS programming and involved in testing and debugging against teh test data.
  • Acquired noledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).
  • Created SAS views from Oracle database tables using SAS/ACCESS and writing SAS code using BASE SAS and SAS MACROS to create SAS reports.
  • Generating SAS programs for creation of tables, listings and analysis datasets for validating teh original programmers output.
  • Reviewed Protocols and provided Listing and Tables as per Statistical Analysis Plan.
  • Performed Edit Checks on teh data received from Data Management.

Environment: SAS9.1.3,SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, Microsoft Office Applications, Windows 2000, Windows NT, UNIX.

Confidential, Richfield, WI

SAS Programmer

Responsibilities:

  • Involved in creation of Analytical Dataset, Generation of SDTM Compliance SAS Dataset, Generation of Tables and Listing, Validating, Mapping and conversion of Non- CDISC SDTM Dataset to CDISC SDTM Dataset as per SDTM IG 3.1.1
  • Analytical Dataset (VS, MH, AE etc.,) creation as per ADS Specification, Data Quality Check and Validation
  • Developing programs to generate SDTM datasets from raw data collected on Case report forms using CDISC standards.
  • Experienced wif teh CDISC SDTM and ADaM models and transforming raw data into these standards.
  • Creation of Safety and Efficacy Evaluation Tables and Listing as per Statistical Analysis Plan
  • Tables and Listing Validation as per teh Standard Operating Procedure (SOP)
  • Document and Analyze results and set up reports containing respective conclusions, ideas and general guidance
  • Reviewing data definition tables for SDTM and derived data sets for assigned studies and provide comments.
  • Provided programming support to produce CDISC compliant databases (e.g. STDM, ODM, ADAM) for regulatory submissions
  • Creating Annotated CRF’s and generation of SAS Reports for Project Team Lead review

Environment: SAS9.1.3,SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, Microsoft Office Applications, Windows 2000, Windows NT, UNIX.

Confidential

SAS Programmer/Analyst Clinical Trials

Responsibilities:

  • Understanding study Protocol, SAP, CRFs. Retrieving teh CRF data in to SAS from teh ORACLE (CRF databases) using SAS/ACCESS and SAS SQL procedures.
  • Generated graphics for reporting purposes using SAS/GRAPH, Proc Tabulate, etc.
  • Created ad-hoc reports using various SAS Procedures, SAS/GRAPH and SAS/STAT for teh functional specification.
  • Involved in data manipulation by merging, appending, concatenating, sorting datasets and also data migration from one platform to another to be used for further clinical analysis.
  • Extensively used Data Null, Proc Freq, Proc Tabulate, Proc Report, Proc Means, Proc Summary, Proc Contents, and Proc Compare.
  • Investigated missing data and data inconsistency in SAS data sets. Developed edit-check programs to clean invalid data from teh database.
  • Created external files mainly RTF and HTML reports using SAS Output Delivery System (ODS).

Environment: SAS/Base, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS SQL, SAS ODS, ORACLE, UNIX.

Confidential

Clinical SAS programmer

Responsibilities:

  • Reading and understanding teh study annotated Case Report Forms, Study Definition documents, software tools and working wif SAS
  • Worked closely wif programmer to gain experience in providing SAS programming support during teh conduct and reporting phases of a clinical trial
  • Assisted in teh production of tables, listings and figures (TLFs) using macros, standard templates and custom SAS code and involved in teh quality control of teh TLFs and documenting teh outcome of teh testing according to teh SOP
  • Read and understood assigned documents, completed intern training and attended meetings as required. Became familiar wif teh methods of gathering clinical trial data and teh Oracle Clinical data base structure
  • Importing and exporting raw data files, manipulate and transform data, combine SAS data sets, create basic detail and summary reports using SAS procedures and handling errors by identifying and correcting data, syntax and programming logic errors.

Environment: SAS/Base, ORACLE CLINICAL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS SQL, SAS ODS, ORACLE, UNIX.

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