Description
Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objectives, Endpoints, Sample size, Randomization, Study populations, SDTM, ADAM, TLF, Statistical Analysis, and Safety). * Works closely with the Biostatistics and Data Management member on various clinical projects. * Review CRF annotations and database data specifications. * Perform analyses defined in the statistical analysis plan as well as ad-hoc analyses as requested. * Extracting the data from various internal and external databases (Oracle, RAVE, Excel spread sheets) using SAS/ACCESS, SAS/CONNECT, SAS/INPUT, Proc Import etc. * Worked on FDA Submission studies as well as Pooled studies in Oncology Therapeutic area. * Comfortable to working in challenging environments under deadlines, excellent analytical and problem solving skills. Project #1 Analysis : Safety and Efficacy Analysis. Role : Statistical Programmer. Description: The objective of the study was to evaluate the safety and efficacy of the study drug, which is given to the subjects with Chronic Myelogenous Leukemia, in chronic phase. This study was very much complex with complex study design, Creation of Datasets and cleaning, Manipulation, Validation of data is done using Data step and Base SAS procedures. The statistical procedures were applied and reports were generated as per the protocol. Submission related programs and documents were created as per SOP's. Roles & Responsibilities: * Created CSR reports using Base SAS & SAS/Reports procedures. * Responsible for converting the business rules to SAS Datasets, which are then used to generate reports. * Analyzed data using SAS/Stat procedures and created SDTM, ADAM datasets compliance with the CDISC * Generated analysis reports, using SAS/Reports * Generated CSR reports which are required while submission to FDA * Generated BIMO listings, SAS pointer documentation. Project #2: * Title : Safety Study of the anxiety Drug. * Role : SAS Programmer Description: * * The purpose of this study was to evaluate the safety and effectiveness of an investigational anti-anxiety medication relatively in the patients with generalized anxiety disorder (GAD) and to determine the pharmacokinetics of this regimen in these patients. The eligibility of the study included both the genders between18-64 years and satisfying the criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations. * * The project involved SAS programming for Phase II clinical trials for generalized anxiety disorder. The reporting process involved various reports like demographics, concomitant medications, vital signs, complete medical history and adverse events. Roles & Responsibilities: * Accessing data from source to SAS environment. * Created both temporary and permanent SAS datasets. * Concatenated, match merged SAS datasets with DATA step process. * Generated derived data sets for the statistical analysis as per SAPs. SAS Procedures Used: Sort, Transpose, Print, Append, Format. Project #3: Role : SAS Programmer Therapeutic Area : Cardiology Description: This project was for the phase II and phase IV studies. Collaborated with Biostatisticians and representatives from clinical to regulatory to develop clinical trial reporting systems, tables, patient listings, case report form tabulations and derived datasets provided by client. Roles & Responsibilities: * Generating standard and non-standard tables on ECG (electrocardiogram) data, Vitals data (Blood Pressure, Pulse Rate), Laboratory Data, Subject Evaluation * Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions. Tested and debugged existing MACROS. * Created SAS reports using the PROC Report for the NDA submission as per the FDA regulations. * Formatted RTF reports using SAS output delivery system ODS.
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