Blessy D Email & Phone Number

• Strong knowledge on SAS programming skills, with proficiency in SAS/Base, SAS/Macros and Proc SQL• Good knowledge on various SAS functions like SCAN, SUBSTR, CAT, TRIM, STRIP, MEAN, RANGE, N, NMISS, CMISS, COALESCE, CEIL, FLOOR, ROUND, ABS, INPUT, PUT, INTCK and INTNX etc., to manipulate data• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data using Statistical Procedures using PROC MEANS, PROC FREQ and PROC TABULATE• Skilled in performing utility procedures such as PROC COPY, PROC SORT, PROC TRANSPOSE, PROC RANK, PROC COMPARE, PROC CONTENTS and PROC APPEND to adjust the data• Trained in using SAS to read, write, import and export to another data file formats, including text files, delimited files, Microsoft Excel and Access tables• Expertise of generating customized reports using DATA _NULL_ method • Trained in producing HTML, PDF, RTF, XLS, and XML formatted files using SAS ODS facility• Skilled in SAS Programming, merging SAS Datasets, SAS macros, generating and validating reports, SAS Formats, storing and managing data in SAS Files• Able to assist in creation of specification sheets & annotated Case Report Forms• Extensive knowledge in creating SDTM datasets such as Demographic Data (DM), Concomitant/Prior Medication (CM), Exposure (EX), Adverse Events (AE), Medical History (MH), Disposition (DS), Vital Signs (VS), Laboratory Test Results (LB) and respective SUPPQUALs• Basic knowledge on validating the SDTM final Domains with Open CDISC Validator (PINNACLE 21) to check the compliance of data with SDTM standards• Trained in annotating CRFs • Able to design Specification sheets which are required for creating SDTM final Domains• In-depth knowledge of Clinical data & CDISC SDTM 3.2 Implementation Guideline• Hands on experience in mapping of raw data to SDTM variables through SAS programming• Strong knowledge of clinical trials methodology, ICH-GCP, GPP, USA FDA and 21 CFR Part 11 guidelines• Good Understanding of Clinical Trial process and involved in all phases (Phase I-IV) of Clinical trials• Good understanding of the procedures in Phases I, II, and III clinical trials studies in therapeutic areas such as Diabetes, cancer etc. • Corporate responsibilities of working towards implementation of CDISC standards• Quick learner and interested in working challenging environment