SUMMARY

• 7 years of experience as a senior SAS programmer in various organizations.
• Good knowledge in CDISC SDTM, ADAM Standards and CRF notations.
• Experience in deliverable like define.pdf and define.xml for generating E - submissions (NDA)
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Involved in submissions and worked on Ad-Hoc reports.
• Integrated data from multiple studies for ISS and ISE.
• Good proficiency in reading SAS data sets and creating variables.
• Worked on Global Macro Validation team to validate the macros used across studies.
• Capable to Import and Export data using importing and exporting techniques in SAS.
• Extensive knowledge in various SAS Products, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/GRAPHS, SAS/ACCESS and SAS/STAT.
• Good Knowledge in SAS Programming, concatenation and merging SAS Data Sets, Macro Facility, Preparing Data, Producing Reports, SAS Formats, SAS Functions, Storing and Managing Data in SAS Files.
• Good skills in producing reports employing various SAS Procedures like Print, Report, Summary, Freq, Tabulate, Means, SQL, and Datasets.
• Knowledge in Conversions of SAS Datasets to various files types (including Excel, RTF, PDF, HTML) as well as converting various file types to SAS Datasets. And have knowledge on listing and summary tables to report the results of clinical trials.
• Good knowledge in all phases of clinical trials.
• Reputed for dedicated teamwork, high-energy with solid work and commitment to achieving various goals and key objectives as set forth by senior management of the company.

TECHNICAL SKILLS

SAS Skills: SAS/BASE 9.1.3, 9.2, 9.3, SAS/MACRO, SAS/CONNECT, SAS-SQL, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACESS

Procedures: Print, Transpose, Contents, Means, Chart, Plot, Tabulate, Univariate, Summary, Sort, Anova, Freq, Format, Import, Export, Report, Gplot, Gchart, Glm, Boxplot, Ttest, Proc Lifetest, Proc Reg, Proc Logistic, Proc Phreg, Proc Corr

Database Platforms: Oracle Clinical, Clin-Trial, MS ACCESS 98/2000

Languages: BASE/SAS, ORACLE, SQL

Design Tools: J-Review, MS Excel, MS PowerPoint, MS Word

Operating Systems: UNIX, Windows 7/vista/XP/NP/2000

PROFESSIONAL EXPERIENCE

Confidential, New York, NY

SAS Programmer/Analyst

Responsibilities:

• Designing, building and testing a series of SAS programs for generation of Data set automatically without giving parameters from outside.
• Developing macros for automatic running of various programs like merging, sorting, printing of ODS files etc.
• Accessing data from Oracle database and SAS data sets/ Importing the initial data from the source files.
• Developed reports using Proc Report, Proc Tabulate, Proc Freq, Proc Means.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS, Windows-XP.

Confidential, Cincinnati, OH

SAS Programmer/Analyst

Responsibilities:

• Designing, building and testing a series of SAS programs for validating and reporting of Clinical Data from a standardized Oracle/Oracle Clinical database for a drug submission to regulatory authorities.
• Accessing data from Oracle database and SAS data sets.
• Developed reports using Proc Report, Proc Tabulate, Proc Freq, Proc Means.
• Developing graphs regarding the response levels of the patient.
• Created Analysis Data Set from raw data sets according to specifications by self-creation based on mock shells and SAP.
• Validated analysis datasets and SAS-generated outputs (tables, listings and graphs) via independent programming.
• Involved in the design and implementation of analysis and programming of reports used for analysing clinical trials data.
• Part of the Quality review group to check the quality of deliverables for other projects. Updated MedDRA versions of older studies to be consistent with newer studies when pooling data across multiple studies for ISS and ISE studies
• Reviewed mock-up tables, listings, analysis datasets specifications and provided feedback to statistician.
• Implemented CDISC SDTM and ADAM Standards.
• Assisted in converting clinical study data to sponsor specified ADaM standards.
• Assisted in the production of derived dataset specifications, programming specifications.
• Interacted with statisticians, data managers, and others to resolve data issues in conversion of SAS datasets into SDTM-and ADaM-compliant structures.
• Used efficacy procedures such as proc logistic, proc summary, proc phreg to create TLG reports as well as datasets.
• Experienced in implementing programming solutions on large data sets.
• Wrote Specifications for SDTM mapping from raw datasets, and for ADaM mapping from SDTM datasets while working on Clinical Data and validation of SDTM, ADaM datasets.
• Involved in creating Transport-files for electronic submissions to FDA.
• Supported ad hoc analyses and OSI listings as a part of NDA submission.
• Worked on Define.xml and reviewed SDRG and ADRG to ensure accuracy and completeness.
• Integrated data from multiple studies for ISS and ISE.
• Produced outputs for conferences and other publications.
• Involved in creating Transport-files for electronic submissions to FDA.
• Reviewed and validated CDISC SDTM and ADAM specifications and program creation, validation, conformance check to ensure accuracy and clarity.
• Produced high quality graphs through SAS/GRAPH for analysis.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones. Helped in creating and debugging global macros which were used in the development of deliverables.
• Involved in CRF Annotation, CRF development, creating edit check programs and provided the feedback to the management.
• Developed and reviewed SAS programs and output.
• Involved in day to day activities related to SAS Programming.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS, Windows-XP.

Confidential

SAS Programmer/Analyst

Responsibilities:

• Converted MS-Excel files to SAS datasets
• Handled dropouts and missing data by using traditional approach of generating Last-Observation-Carry Forward (LOCF) data on visit-wise data.
• Involved in writing SAS macros and using global SAS macros
• Reviewed mock-up tables, listings, analysis datasets specifications and provided feedback to statistician.
• Analysed raw data and provided input to statisticians regarding analysis dataset specifications
• Maintained and updated existing utilities as per project requirements
• Used department macros for report generation.
• Involved in CRF Annotation to ensure that required data is captured completely
• Used SAS/ODS for generating different output formats as requested
• Analysed existing processes and replaced them with more efficient processes
• Implemented CDISC SDTM and ADAM Standards.
• Worked on Define.xml and Define.pdf.
• Reviewed and validated various CDISC SDTM and ADAM specifications.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Developed and reviewed SAS programs and outputs.
• Involved in day to day activities related to SAS Programming.
• Carried out all activities according to SOPs.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS, Windows-2000.

Confidential

Statistical Programmer/ Analyst

Responsibilities:

• Analysed feedback data of the client and developed customized reports according to the requirements
• Produced data listings, summary tables and graphics for interim and final analysis and publications.
• Provided data in SAS transport files, and other appropriate deliverables and documentation for regulatory submissions.
• Performed validation programming on clinical trial data using SAS MACROS.
• Created base macros to run reports.
• Creating standard reports to use across studies and creating base programs to set up data.
• Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and graphs.
• Produced ADHOC reports for presentation and further analysis.
• Performed quality controls (QC) on SAS programs.
• Documented all project data flows and programs.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/ODS, Windows-XP.