Statistical Programming

• Subject Matter Expert & SAS programmer.
• Has excellent understanding of different phases of Clinical trials , Safety and efficacy data, clinical trial designs and ethical conduct
• Subject Matter expert in SDTM, CDASH and ADAM
• Generating Reports, ADS (Analysis datasets) and TLF (Tables, Listings and Figures) as per Statistical Analysis Plan and Business Document
• Good analytic skills combined with ability to manage large amount of data
• Well acquainted with SAS and SQL, PL-SQL
• Involved in and out delivery of FDA compliant target datasets, annotated aCRF, Trial Design Domains, SDTM domains, maps and analysis document.
• Write detailed specifications for normalized and analysis data sets
• guided all staging fixes of recent submissions by validating metadata, domains and aCRF
• Act as Data Analyst (SAS Programmer) to produce analysis datasets as specified in the Statistical Analysis Plan
• Create, validate, execute, and document SAS programs that produce outputs (analysis datasets, tables, listings, and figures) from source data
• Write SAS edit checks from Data Management Plan
• Ensure SAS program output adhere to specifications and requirements of the Statistical Analysis Plan