SUMMARY

• SAS Developer/ Analyst with Eight years of SAS/R/Python programming experience, providing statistical programming support for multiple clinical research projects in pharmaceutical, biotechnology and contract research organization (CRO) industries. Certified in CDISC, SDTM & ADAM standards.
• Six years of experience in SAS Enterprise miner and SAS DI Studio. Expertise in concepts of Time Series, Hypothesis Test, ANOVA, RFM analysis, Customer LTV and ARIMA models
• Adept at Advanced Predictive Models, Credit Scoring Models, Customer Segmentation/ Profiling, Sentimental Analysis, Market Basket Analysis & Text Mining Techniques.
• Deduced significant variables like declined/defected from variable selection method, gathered inter dependencies by Cross - Tabs/Paired T-tests & built model using Logistic Regression.
• Extensively worked on Phase I to Phase IV clinical trials data for various studies including Oncology, Dermatology and Neurology.
• Advanced SAS programming experience with Version 9: SAS/BASE, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/ASSIST, SAS/MACRO, SAS/SQL and SAS/ODS in Windows and UNIX environments.
• SAS programming experience with selection of appropriate statistical methodology, data analysis, summarization, reporting and submission for all four phases of Clinical Trials: Phase I, Phase II, Phase III and Phase IV (Post-market study).
• Advanced skills on data cleaning and manipulation using procedures such asPROC SUMMARY, PROC SORT, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC FORMAT, PROC TRANSPOSE, PROC PRINT, PROC REPORT, PROC TABULATE, PROC COMPARE, PROC CDISCand many SAS data steps such asARRAY, MERGE, SET, etc.
• Extensively used Dynamic Data Exchange (DDE) for importing / exporting data from Excel sheets into SAS and to another data file formats, including delimited files, DBF, MDB, Spreadsheet files.
• Strong understanding of FDA regulations such as CDISC, MedDRA, ICH and GCP guidelines and other Regulatory Submissions (NDA, including an ISE and ISS)
• Estimated Value at risk, using techniques historical simulation and Monte-carlo simulation used R programming.
• Prepared SDTM Version-3. 1 and AdaM-Version 2.0 data sets as per CDISC standards.
• Worked on CRT Data set creation from clinical trial data, CDISC and MedDRA for regulatory submissions. Customized SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations according to the company guidelines.
• Possess working knowledge of data collection and data cleaning(Google analytics, pandas(python)), with strong ability to interpret data(matplotlib,Ggplot2),visualization & classification & clustering data, and use statistical tools in modeling, analysis and reporting (rpy2,Latex),MLE, UMVUE, OLS, ANOVA,DOE,ARMA,GLM.
• Five-year experiences in developing advanced analytical toolkits & algorithms using SAS and R.
• Worked with Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (lab data), physical and vital signs and Audit Trials. Generated ad-hoc reports as necessary for studying specific trend/ causal effects. Created CRT’s (Case Report Tabulations) using CDISC standards for submissions to the FDA. Used XML for data formatting that fits the FDA’s strategies for electronic submissions.
• Recorded computer validation inspections in compliance with 21 Code of Federal Regulations (21 CFR, Part II). Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with (21CFR) Part11, FDA and other regulatory compliance.
• Contributed to the preparation of Statistical Analysis Plans. Prepared, documented and tested required programs and procedure data displays in an efficient manner for inclusion in integrated clinical statistical reports and other similar reports. Thorough knowledge of clinical reporting process including the documentation involved in it.
• Used SAS 9.4 Grid Manager, for effectively managing the use of SAS® Enterprise Guide® in a grid environment.

TECHNICAL SKILLS

SAS Tools: SAS V9, SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/ SQL, SAS/ MACROS, SAS/REPORT, SAS/ GRAPH, SAS/STAT, SAS/ODS.

Databases: Oracle Clinical, Clinic-Trial.

Operating Systems: UNIX, Linux, Windows 7/vista/XP/NT/2000

Languages: Java, Python, R, SQL, PL/SQL, C, UNIX- SHELL SCRIPTING and FORTRAN, SPSS, Tableau

Office Tools: MS-OFFICE, Word, Excel, PowerPoint

PROFESSIONAL EXPERIENCE

Confidential, Atlanta, GA

Clinical SAS Programmer

Responsibilities:

• Developed and reviewed SAS programs and output for the management and reporting of clinical trial data. Utilized SAS based systems to assist and facilitate Clinical Data Management activities.
• Practiced preparation of Programming Plans, study set-up and review of study specific documents.
• Used Macros to produce Data Definition Documents (DDDs) for NDA submission and annotated Case Report Forms (aCRF) to the dataset. Merged electronic data with the CRF.
• Worked on Phase II and Phase III Clinical Trial data for Metastatic Melanoma including Primary and Secondary endpoints data.
• Performed routine quality check on datasets, DDDs, aCRF to ensure their accuracy according to the client specifications.
• Provided SAS programming and analysis report for phase oncology clinical Trial.
• Worked on Phase I and Phase II clinical data to generate CDISC compliant datasets. Responsible for various clinical data studies to create datasets and associated documents in a timely manner.
• Involved in writing, editing, validating, debugging code and developed new SAS programs and modified existing datasets using Set, Merge, Sort and ProcSql with various SAS functions.
• Routine quality checks were done for TFLs to ensure their accuracy to meet the client specifications. Provided appropriate feedbacks wherever necessary.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Compiled TFLs at appropriate intervals during the study process. Documented the TFL updates spreadsheet and performed requested changes to TFLs following the Pre-Lock Meeting and Data Review Meeting.
• Applied CDISC and FDA regulatory requirements, including the Annotated CRF (aCRF) from the metadata.
• Developed SAS programmable edit checks to assist in data review as needed. Answered QA audits in an accurate and timely manner.
• Used SAS and R for regression modelling of covariates on survival outcome to compute pseudo values.

Environment: SAS V 9.4, Linux, Windows XP SAS Base, SAS Stat, SAS Graph, SAS SQL, SAS Macros, SAS Access, MS-Excel

Confidential, Washington, DC

Risk Analyst - CDO Clinical Development & Ops/ SAS Administrator

Responsibilities:

• Developed a pre-processing trend model to isolate and monitor credit risk metrics (PD, LGD, EAD) for corporate-wide loan portfolios, created monthly trend reports using Excel VBA, reduced production time by 40% and ensured data integrity (SAS/SQL, Access, Excel VBA).
• Constructed static consumer debt (credit card) data pools and calculated credit-score-bucket transition probabilities, delinquency and charge-off rates for loan performance tracking and further predictive default and correlation modeling (SAS, Excel).
• Researched capital simulation models and prepared input data tables for measurement of risk capital through Monte Carlo-VaR methodology to satisfy capital adequacy requirement.
• Streamlined and aggregated non-modeled portfolio data across disparate systems and sources with SAS/Access.
• Supported the analysis and reporting functions that surrounded the Risk Management processing. Created, modified, or enhanced three functional areas of assessing the Value at Risk or "VaR".
• Proposed an earnings-volatility Excel model to indicate corporate credit downgrade risk.
• Controls all PII data and changes to the MilPER data systems at all levels relating to data usage while working with Blue wireless, mobile service provider.
• Respond to Electronic Spillage incidents where classified, Personal Identifiable Information (PII), Controlled Unclassified Information (CUI), or Networks of Interest (NOI) information is introduced on an IT system or network that it is not authorized to hold or process such data.
• Reviews records and reports in a timely manner as required by operations, rehabilitation, and human resources departments as well as the contractor.
• Interfaces with contract personnel on all routine matters pertinent to contractual obligations.
• Used WEKA with Java (eclipse) for regression, classification and clustering modelling.

Environment: SAS V 9.4, SAS V 9.2, Linux, Windows XP SAS Base, SAS Stat, SAS Graph, SAS SQL, SAS Macros, SAS Access, MS-Excel

Confidential, Round Lake, IL

SAS Programmer

Responsibilities:

• Worked with clinical trial datasets and clinical reporting in phase I - phase III studies using SAS.
• Responsible for manipulating, transferring and managing clinical trial data in SAS. Working with SAS Analysts in clinical data programming and data processing.
• Broadly involve in analyzing and coordinating clinical trial data, generating reports and TLG’s.
• Successfully designing and implementing statistical report processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
• Functioning with Data Management Group to create data clean and data validation listings. Using Edit checks regularly for the detection of new errors and the identification of data points with outstanding Data clarification requests (DCR). Use of Last-Observation-Carried-Forward (LOCF) method for clinical trial analysis for handling missing data and dropouts.
• Handling the tasks of extracting data from the database using SAS Access, SAS SQL procedures and creating SAS data sets.
• Apply Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS, MS Access and Excel.
• Handling the maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for creating Reports and Graphs.
• Assigning the tasks for creating new datasets from raw data files using import techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Produced complex and reusable Macros and widely used existing macros and developed SAS programs for data cleaning, validation, and analysis for report generation. Tested and debugged existing macros.
• Generating Tables, Graphs and Listings for clinical study reports and regulatory submissions; Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Using PROC SQL extensively to perform queries, join tables.
• Working with Bio-statisticians to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM and mixed models.
• Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate. Using Data Null technique for producing highly formatted outputs and highly customized reports.
• Generating reports either in HTML, PDF or RTF format according to the client specifications.
• Acting as a bridge between Data Management and Clinical department communicating with users, programmers and management.
• Creating CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA. Strong understanding of FDA regulations such as CDISC, MedDRA, 21 CFR Part 11, ICH and GCP guidelines and other Regulatory Submissions (NDA, including an ISE and ISS).
• Attending project team meetings, worked with bio-statisticians, data management team, and clinical research managers as appropriate. Worked on multiple projects simultaneously and met the deadlines as and when required.
• Used python programming to build a clinical decision with IF, THEN logical statements.

Environment: SAS V 9.3, SAS V 9.4, Linux, Windows XP SAS Base, SAS Stat, SAS Graph, SAS SQL, SAS Macros, SAS Access, MS-Excel

Confidential, Madison, WI

SAS Programmer/ Clinical Data Analyst

Responsibilities:

• Utilized SAS proc and other SAS applications for data updates, data cleansing and reporting
• Preparing and Classifying Clinical Trial Data
• Importing Relational Databases and Clinical Data Management Systems
• Transforming Data and Creating Analysis Data Sets
• Creating Tables and Listings and Common Clinical Trial Graphs
• Performing Common Analyses and Obtaining Statistics using PROC FREQ and PROC UNIVARIATE
• Exporting Data to the FDA using the SAS XPORT and creating XML Files

Environment: SAS 9.3, SAS V9.2, SAS BASE, SAS SQL, SAS ODS, Windows XP, Excel/Access 2000.

Confidential

SAS Programmer

Responsibilities:

• Utilized SAS proc and other SAS applications for data updates, data cleansing and reporting
• Preparing and Classifying Clinical Trial Data.
• Importing Relational Databases and Clinical Data Management Systems
• Transforming Data and Creating Analysis Data Sets
• Creating Tables and Listings and Common Clinical Trial Graphs
• Performing Common Analyses and Obtaining Statistics using PROC FREQ and PROC UNIVARIATE
• Exporting Data to the FDA using the SAS XPORT and creating XML Files

Environment: SAS V8, SAS V9.2, SAS BASE, SAS SQL, SAS ODS, Windows XP, Excel/Access 2000.

Confidential

Trainee/ SAS Programmer

Responsibilities:

• Worked with clinical trial datasets and clinical reporting in phase I - phase III studies using SAS.
• Responsible for manipulating, transferring and managing clinical trial data in SAS. Working with SAS Analysts in clinical data programming and data processing.
• Broadly involve in analyzing and coordinating clinical trial data, generating reports and TLG’s.
• Successfully designing and implementing statistical report processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
• Functioning with Data Management Group to create data clean and data validation listings. Using Edit checks regularly for the detection of new errors and the identification of data points with outstanding Data clarification requests (DCR). Use of Last-Observation-Carried-Forward (LOCF) method for clinical trial analysis for handling missing data and dropouts.
• Handling the tasks of extracting data from the database using SAS Access, SAS SQL procedures and creating SAS data sets.
• Apply Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS, MS Access and Excel.
• Handling the maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for creating Reports and Graphs.
• Assigning the tasks for creating new datasets from raw data files using import techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Produced complex and reusable Macros and widely used existing macros and developed SAS programs for data cleaning, validation, and analysis for report generation. Tested and debugged existing macros.
• Generating Tables, Graphs and Listings for clinical study reports and regulatory submissions; Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Using PROC SQL extensively to perform queries, join tables.
• Working with Bio-statisticians to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM and mixed models.
• Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Generating reports either in HTML, PDF or RTF format according to the client specifications.
• Acting as a bridge between Data Management and Clinical department communicating with users, programmers and management.
• Creating CRT datasets using CDISC standards for submissions to the FDA. Strong understanding of FDA regulations such as CDISC, MedDRA, 21 CFR Part 11, ICH and GCP guidelines and other Regulatory Submissions (NDA, including an ISE and ISS).
• Attending project team meetings, worked with bio-statisticians, data management team, and clinical research managers as appropriate. Worked on multiple projects simultaneously and met the deadlines as and when required.

Environment: SAS 9.2, Linux, Windows XP SAS Base, SAS Stat, SAS Graph, SAS SQL, SAS Macros, SAS Access, MS-Excel.