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Title Data Management Clinical
Target Location US-IL-Chicago
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Candidate's Name
Email: EMAIL AVAILABLEMobile No: PHONE NUMBER AVAILABLEOBJECTIVESAS/ Statistical programmer with over 2+ years of experience in data management and statistical programming in various phases of clinical trials working for pharmaceutical companies and Clinical Research Organizations (CRO). Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving analysis, design, development, testing and validating the applications.PROFESSIONAL SYNOPSISExcellent ability to read SAS data sets and create variables.Excellent knowledge of clinical trial phases, clinical protocols, CRFs, and annotated CRFs.Experience P21 validation.Developing SDTM Spec and SDTM Domains based on Annotated CRF.Generating and Validating Pinnacle Report (OpenCDISC Validator) to check the compliance of final SDTM datasets with SDTM IG standards.Experience in generating safety tables such as DM, SV, AE, CM, MH, VS, etcExperience in data mapping from SDTM to ADaM.Experience in creating specifications for ADaM (ADSL,ADAE,ADLB,ADVS).Extensive knowledge in SAS Products, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/REPORT.Exceptional report-creation abilities with SAS Procedures such as Print, Report, Freq, Transpose, Means, Contents, Formats, and SQL.Exporting and importing data from other databases by using PROC IMPORT/EXPORT procedures.Generated reports using PROC REPORT, DATA _NULL_ for customized report writingExperience in developing, validating, and implementing SAS programs and producing derived datasets for analysis and generating & documenting tables, listings for clinical study reports.Good experience in validation of ADaM datasets, Tables, and listings.Used ODS to display outputs in HTML, CSV, TXT, or other file formats.Missing data handling using LOCF, BOCF concepts and written analysis files specifications for various therapeutic areas.Have a good ability to rapidly adapt to new applications and platforms.Excellent team player with good analytical and communication abilities.PROFESSIONAL EXPERIENCEFL Tech Solution LLCStatistical Programmer May2021-PresentProject -1A Phase 1b Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilator Effect in Patients with Chronic Asthma.Responsibility:-Developed SAS programs to perform edit checks on clinical data received from CROs and internal data warehouse.Performed Data analysis, statistical analysis, generated reports, listings, and graphs using SAS/Base, SAS/Macro and SAS/Graph, SAS/Access, SAS/ODS.Analyzed data using SAS Statistical Procedures such as Proc Means, Proc Tabulate, Proc Freq, Proc Summary. Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Data Steps, Set, Merge, Sort, and Update, Formats, Functions, and conditional statements.Developed numerous SAS programs to create summaries and listingsGenerated customized reports using the DATA _NULL _ and PROC REPORT.Used ODS to create deliverable documents.Validated the derived datasets using proc compare and resolving the Errors/Warnings/Notices accordingly.Following Client SOPs and Meeting Deadlines.TECHNICAL SKILLSMS Office : Excel, Access, WordSAS Tools : SAS/BASE, SAS/SQL, SAS/MACROS and CDISC( SDTM, ADAM,TLF's)Operating System : Windows, UnixDatabase : Oracle, SQL serverACADEMICSMasters Of Business Administration June2009- May 2011(Osmania University)CERTIFICATIONSSAS Certified Specialist: Base Programming Using SAS 9.4Received certification on completion of SAS 9.4 BASE from institute of clinical SASReceived certificate on completion of SDTM CDISC ADAMS StandardsDECLARATIONI hereby solemnly declare that all the information provided here is genuine as per the best of my knowledge.Place : CHICAGO SIGNATURE:(Candidate's Name )

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