Description
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). * Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, and Protocols of clinical trials * Good team leader with attitude to constantly strive to mould to the dynamic requirements in a competitive workplace * Experience in implementing CDISC SDTM for intervention, event and findings domain models and ADaM standards, knowledge of SDTM terminologies, Define.xml * Performed Data Analysis validation and created programs as per the specifications * Knowledge of using Jreview/Ireview, familiar Data bases like Oracle clinical, Inform, Medidata Rave, clin-Trial, external vendor systems for central lab, IRT data etc. * Extensive Knowledge of Clinical Trials and electronic submissions in various in therapeutic areas like Oncology and Cardiovascular. * Hands on experience in SAS BASE, SAS ACCESS, SAS CONNECT, SAS ODS, SAS MACRO AND SAS SQL. * Proficient in Providing Data Standards for Clinical studies, Creating test data, format catalogs, and validation of clinical study database design. * Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM standards. * Experience on CDASH standards implementation and OPEN CDISC review for the submission studies. * Experience in extracting data from various data sources such as Oracle and Access databases, Excel Spreadsheets and flat files and creating SAS datasets * Experience in handling data from External Vendors for various header and data reconciliations. * Involved in writing edit check Macros, validation of analysis datasets. * Experience in working with Statisticians for analysing Clinical Trial Data and generating reports containing tables, listings and graphs in accordance with the Statistical Analysis Plan (SAP) and Standard Operating Procedures (SOPs). * Understands the major bio statistical deliverables (Analysis Plan, CSR), and the process of * developing publications for external consumption (abstracts, posters, slide decks, manuscripts). * Worked with Biostatistician to provide SAS programming for analysing clinical trial data and generating TFLs. * Experience in coordinating with Clinical Data Management (CDM) Lead, Statistical Programming * Lead and Biostatistician for queries related to clinical study data, analysis and report generation. * Good understanding of FDA regulations (21CFR PART 11), ICH and guidelines in new drug development and application Process.
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