Skills Capabilities Summary

• Oracle and SAS certified programmer with 7 years of experience in software programming with 5 years in Clinical Data Management and Analytics
• Experience in Phase I to Phase IV of Clinical Trial studies and familiar with ICH, GCP, CDISC ODM, SDTM, ADaM, 21 CRF Part 1, FDA, IND,NDA, ICD and HIPPAA
• Extensive experience in SAS/BASE, SAS MACRO, SAS/STAT, SAS/ACCESS, SAS PC, SAS GRAPH
• Experience in extracting data and creating SAS datasets from different data sources like Oracle database, Access database, Excel , Flat files using SQL Pass through facility and Import techniques
• Proficient in concepts of Data Cleaning, Data Mapping, Data Mining, HASH programming and Statistical methods descriptive statistics, linear and logistic regression, correlation analysis, etc.
• Automate analysis and reporting process with SAS Dynamic Data Exchange DDE
• Predominantly used Advance SQL queries and created database objects using PL/SQL
• Expertise of Oracle Clinical Data Structures, Study Build, Annotations, PRS System and SQL Checks and writing Derivation and Validation Procedures and JReview Reporting.
• Exposure to Clinical Data Management processes from CRF designing to FDA Submission process
• Strong written verbal and inter personal skills and work in collaboration with team members
• Quick learner and hard worker, easily adaptable to newer tools and technologies

Responsibilities

• Include screen asymptomatic individuals for evidence of disease, conclude definitive diagnosis based on differential diagnosis, follow course of disease in patients and assess treatment impact
• Perform descriptive statistics and Inferential statistics and write appropriate mathematical models
• Screen asymptomatic individuals for evidence of disease, conclude definitive diagnosis based on differential diagnosis, follow course of disease and assess treatment impact
• Write the SAS and R programs to build data structures, sorting, statistical analysis, testing and maintenance. Perform presentation, interpretation and reporting to data managers on finding

Confidential

SAS Clinical Programmer/ Business Analyst

esponsibilities

• Created and maintained SAS datasets extracted from the database
• Manipulated dataset using Set, Merge, Sort, Hash
• Created SDTM, ADaM SAS datasets and validated using SAS QC Macros for the QA
• Created Transport Xport files, LOCF,BOCF, WOCF
• Developed Macro program to send SAS procedure output to different destinations such as HTML, PowerPoint and PDF and automated the process using DDE Dynamic Data Exchange
• Created trial related Analysis and derived datasets as and when required and Document all programs as per the company standards
• Developed reports in TIBCO SpotFire for web publishing
• Work with the project manager about various data issues and resolve queries
• Support multiple therapeutic areas like Primary care, different specialties within primary care, Oncology, Managed care creating updating the datasetsConfidential
• Scientific Programmer

Tools And Technologies

Windows 2007, MS Access, SAS on Windows, R for Windows, R packages

Responsibilities

• Performed data analysis and statistical analysis using SAS Base and SAS Macro
• Export data from Electronic health record and used dynamic data exchange and PROC Import to input data from excel sheets
• Developed SAS programs for Data cleaning, Validation, Analysis and Report generation
• Extensively used PROC FORMAT, PROC REPORT, PROC SUMMARY, and PROC TABULATE while generating reports.
• Converted SAS datasets to various file types and converted various file types to SAS datasets
• Performed data analysis on datasets using PROC ANOVA, PROC GLM,PROC MEAN, PROC UNIVARIATE, PROC REG, PROC LIFESPAN, PROC PHREG
• Formatted HTML, RTF and PDF reports using SAS output delivery system
• Proficient in generation graphs using SAS Procedures PROC GPLOT, PROC PLOTS, PROC FREQ PLOT OPTIONS
• Effectively used many SAS Functions and applied advances logic to manipulate datasets.
• Statistical methods like Probability, Bayesian methods and Survival analysis are used for further analysis to look for specific renal disease looks analyzing all biomarkers climate, family , cell biology of different kidney cells to renal physiology and pathology of biological and clinical importance.
• Generate reports that evaluate the diagnostic value of medical tests and evaluate the treatment value of therapeutic procedures.
• Use R programming to draw graphs showing the patient's susceptibility to infection and the changes to the risk of infection over time.
• Summarizes results of data analyses in written reports and oral presentations to management and physicians as required.
• Developed programming standard document for Data management department

Confidential

Clinical Report Programmer

Tools And Technologies

Windows 2007, Oracle 11g, UNIX, SAS CDI, Oracle Clinical, SAS/ACCESS, SAS/MACRO, SAS/SQL, SAS/GRAPH, JReview 8, SQL, PL/SQL, SQL Developer, SQL Navigator, Documentum

Responsibilities

• Create SAS/ SQL programs for Clinical studies Phase I through IV within different therapeutic areas like Anti-Infectious, Cardiovascular, Immunology, Metabolic and Central nervous system.
• The SAS Listings and Tables, Patient profiles, Graphs, Cross tabs, formatted Summary listing are created based on database design, DRP data review plan following SOPs Standard Operating Procedures and SAP
• Developed SAS programs to generate baseline, follow-up, drug safety reports from database
• Involved in writing edit check programs to clean invalid data from the database and provided inputs to data managers for finalize the edit checks
• Created derived merged and pooled datasets, listings and summary tables for clinical study report
• Generated various data listing, tables, graphs using DATA STEP and Base SAS procedures such as PROC SORT, PROC MEAN, PROC DATASETS, PROC TRANSPOSE, PROC CONTENTS, PROC FREQ
• Build SAS Macros for data cleaning, data mapping CDISC SDTM and reporting.
• Develop TLFs, analysis datasets ADAM and generate primary and derived secondary SAS datasets as per CDISC ADaM specification
• Created complex reusable macros and extensively used existing macros after modifying as per the requirement.
• Generate Clinical trial Global standard reports, MedDRA/WHO Dictionary reports, Study Conduct reports, Functional reports like Discrepancy reports, Adjudication reports, Reconciliation reports for FDA Submission.
• Developed ad-hoc reports for safety and efficacy of the clinical studies, as per the specification that were provided by the SAS
• Coordinate with clinical staff of different teams to write report specification and define timeline
• Provided programming support to data management and statistical programming teams

Achievements

• Recipient of summit award for being a business operator
• Has built a software Riga Case Manager for capturing daily task information for a PharmacoVigilance
• Submitted ideas to save time and increase productivity and performance.
• Has successfully mentored three batches of new hire/other staff in process training.