Experience in data mapping from non-CDISC SDTM to SDTM.
Good Knowledge in Clinical SAS Programming and various processes in Clinical Development.
Well- versed with ICH GCP, CDISC, SDTM3.2 format implementations and 21CFR Part 11 and GCDMP guidelines and regulations.
Good knowledge of processes for planning, conducting, and data processing of clinical trials data.
Good knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical trials.
Experienced in data analysis, data manipulation, data reporting using SAS and relational databases.
Optimized performance using Data Validation and Data cleaning on Clinical Trial data using Statistical procedures like PROC SORT, PROC CONTENTS, PROC FREQ, PROC MEANS, PROC SUMMARY and PROC UNIVARIATE, PROC COMPARE, PROC TRANSPOSE, PROC COPY.
Involved in First in human, Phase I, II and III clinical trials by providing required tables and listings.
Ability to work on multiple projects simultaneously and meet the deadlines as and when required.
Generate reports either in HTML, PDF or RTF formats according to the client specifications..
Extensive use of PROC SQL to perform queries, join tables.
Flexible, multi-tasking and comfortable working in a consistently busy environment.
Excellent communication and interpersonal skills.
Good analytical, problem solving skills along with high leadership quality and able to work independently and in a team environment .
Around 3.5 years of experience as Clinical SAS programmer at ‘AET laboratories’ in analysis, design, development, testing of projects regarding pre-clinical and all phases of clinical trials.
