Ramya Bhatt

• Create summary tables, listings and graphs as per statistical analysis plan.
• QC summary tables, listings and graphs as per statistical analysis plan.
• Created and reviewed tables and listings mocks, ensuring internal consistency and comprehensive display of all CRF fields.
• Review clinical data for outliers, invalid and illogical data points.
• Interact with Clinical Data Management (CDM) to resolve data issues.
• Must be able to use univariates, frequencies, Proc Transpose, and macros, including modifying existing macros and writing macros.
• Follow all pertinent SOP's and guidelines concerning programming and the change control management of all files generated by the Biometrics Programming group.
• Program routine data displays, such as data listings, according to the approved statistical analysis plan and shell displays for clinical research studies. Write code using Base SAS programs, SAS procedures, or standardized macros.
• Write and compare independent QC programs to verify the output generated for data displays.
• Coordinated QC project teams for large projects, training and delegating QC tasks to ensure quality standards.
• Create and maintain standard QC documentation.
• Send tables and listings to clinical writers and clients, which includes printing, collating, and filling out appropriate shipping paperwork.
• Respond to non-statistical questions from Clinical Writing and from clients.
• Assisted in establishing departmental processes and interactions with other departments, contributing to staff training and administrative efficiency.
• Experience in various data management skills like Merging, Handling missing values, Reading raw datafiles, Creating data structures, Handling programming errors, Accessing and Managing data, Concatenating and Interleaving of sas datasets etc.
• Well versed with using datastep, sas formats, informats and functions, data manipulations & report.
• Data managing like subsetting, new variable creation, combining data for analysis, validating and cleaning.
• Worked on Arrays and Functions for data cleaning and data manipulation.
• Data access into sas from raw data using LIBNAME, PROC IMPORT and PROC SQL and transferring data from sas environment to external using PROC EXPORT.
• Expertise with SAS/BASE, SAS/MACRO, SAS/SQL, and SAS/ODS(RTF, PDF) procedures.
• Having knowledge on creating Macro variables, Macro programs and Autocall macro library to modify existing sas program for ease of modification while maintaining consistency of results.
• Worked on various procedures like PROC PRINT, PROC REPORT, PROC FREQ, PROC MEANS, PROC TRANSPOSE, UNIVARIATE,PROC SORT and PROC SQL.
• Generated various safety tables and their reports using PROC REPORT, PROC MEANS, PROC FREQ, PROC TRANSPOSE and MACRO STATEMENTS as per mock shells using analysis datasets.
• Working knowledge on various domains like Demographic data [DM], Vital signs [VS], ECG test results [ECG], concomitant medication [CM] etc.
• Good knowledge in Phase I –IV of clinical trials and clinical terminology.
• Familiar with ICH, GCP, CDISC and FDA guidelines.
• Ability to interact with different functional areas with Excellent Interpersonal, Written and Presentation skills.

¨ Created derived datasets and produced reports using SAS/BASE, SAS/MACRO, SAS/STAT and SAS/GRAPH.

Generated tables, listings, and reports per SAP standards using PROC FREQ, PROC TABULATE, PROC MEANS, PROC SUMMARY, and PROC FORMAT.

Conducted statistical analyses, including descriptive statistical summaries, analysis of variance, categorical analyses, logistic regression, and survival analyses using PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ, PROC ANOVA, PROC GLM, PROC LOGISTIC, and PROC LIFETEST.

¨ Conduct and generate the Regression, Correlation studies and Analysis of Variance using PROC REG, PROC CORR, PROC GLM, and PROC ANOVA.

¨ Import datasets from different sources like a spreadsheet of Excel, flat file, Access, and data file with delimiters etc.

Organized datasets for statistical analysis by merging, combining, splitting, coding, and performing edit-checks to ensure quality.

¨ Create chart, graph and plot using PROC GCHART and PROC GPLOT.

¨ Created SAS customized reports using DATA _NULL_.

¨ Customize SAS outputs to RTF, PDF and HTML formatted files through Output Delivery System (ODS) facility