SUMMARY

• Having 7 years of experience as SAS Programmer Analyst in Pharmaceutical / CRO industry.
• Developed SAS Programs to produce and validate analysis datasets, listings, graphs and summary tables of safety and efficacy data for Phase I - III clinical trials.
• Strong working knowledge in clinical trial data analysis, generating reports and summary tables, listings and graphs as per Statistical Analysis Plan SAP and protocol specifications.
• Excellent experience in SAS programming using BASE SAS, SAS/ACCESS, SAS/GRAPH, SAS/MACRO, SAS/SQL, SAS/ STAT.
• Strong skills in working with various SAS versions and BASE SAS, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS.
• Extensive programming experience with PROC SQL, PROC REPORT, PROC ACCESS, PROC GPLOT, PROC SORT, PROC GCHART, PROC FORMAT, PROC TRANSPOSE, PROC PRINT, PROC COMPARE, PROC APPEND, PROC IMPORT/EXPORT.
• Hands on experience in implementing CDISC standards SDTM and ADaM.
• Modified existing SAS programs and created new programs using SAS MACROS to improve ease and speed of modifications as well as consistency of results.
• Experienced in analysing the clinical trials and generating reports, tables, listings and graphs for internal purpose and for FDA according to the 21 CFR Part 11.
• Experienced with CDISC defined SDTM, ADaM data model standard for transforming and creating analysis dataset for generating TFL’s.
• Experienced on working with legacy data to convert them to CDISC requirements.
• Experienced in creating non-standard ad-hoc requests as per statisticians demand.
• Good understanding of complex SAS concepts like macros, SAS arrays and Proc sql.
• Knowledge of generating electronic deliverables submissions.
• Familiar with IND and NDA submissions, Clinical Terminology and Regulatory Guidelines for FDA submissions.
• Worked on Open CDISC validator to ensure data is compliant with CDISC standards.
• Generated several permanent outputs in RTF format per client's requirement using SAS/ ODS and Proc report.
• Experienced on creating efficacy datasets and efficacy tables using statistical procedures.
• Exceptional problem solving skills for delivering useful and prudent solutions.
• A quick learner with an eye for detail and excellent analytical and quantitative skills.

TECHNICAL SKILLS

Operating System: Unix, MS-DOS, Windows 98, XP, Vista, Windows 7

SAS: SAS/BASE, SAS/PROCs, SAS/MACROS, SAS/ACCESS, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/REPORT, SAS/STAT, SAS/CONNECT, TRANSPOSE, CONTENTS, IMPORT, EXPORTSAS/TABULATE SAS PLOT SAS/MEANS

Databases: RDBMS, Oracle 11i/10g, SQL, MS ACCESS

Programming Languages: SAS 9.2, SQL, C, Object Oriented Programming OOP, HTML

Office Tools: MS-Office 97/2000/03/07/10 , MS-Excel, MS-Power Point, MS-Word, MS-Paint, MS-Access, MS-Outlooks, MS-Communicator

PROFESSIONAL EXPERIENCE

Confidential, Chandler, AZ

SAS Programmer

Responsibilities:

• Responsible for SAS programming (SAS/BASE, SAS/ MACROS, SAS/SQL, SAS/ODS, SAS/ stat, SAS/ Graph) and validation of SDTM, ADaM datasets following specifications and TLFs as per TLF Shells.
• Highly efficient in handling various SDTM domain classes like special-purpose, interventions, events, findings, findings about, Trial design models.
• Created specifications and involved in programming/validation of ADaM datasets from SDTM datasets, ADSL, ADAE, ADMH, ADCM, ADLB, ADDV, ADEX, ADVS, ADEG, ADTTE and analysis Questionnaire datasets etc.
• Running Open CDISC Validator/Pinnacle 21 and addressing the errors and warnings on multiple studies and helping/guiding the teams.
• Worked as Validator on multiple studies, provided quality outputs to the client. And created an internal checklist for thorough validation process for SDTM, ADaM and TLFs for programmer’s reference.
• Created standard macros and applications to improve the working efficiency of the department.
• Involved in creating various SAS Reports satisfying the 21CFR-11 Code for Federal Regulations for electronic data submission.
• Provided input into planning documents such as validation plan, statistical analysis plan, and TFL templates as per AdaM Standards.
• Extensively used internal macro tools in creating mapping specifications documents, creating common header variables across all extracted datasets, handling global appending/merging, checking attributes conformance with SDTM/ADaM and Tables production and validation.
• Expertise in handling Analysis of the data, performing CTCAE grading, Missing data imputation using LOCF/BOCF/WOCF, Visit windowing etc.

Confidential, Boston MA

SAS Programmer

Responsibilities:

• Extracted datasets from database using SAS/ACCESS, LIBNAME Statement and other Import methods.
• Verified accuracy and integrity of Clinical data by performing validation checks written in SAS and data cleaning by investigating data related errors and missing values.
• Reviewed clinical study protocols, case report forms and statistical analysis plans for clinical trials.
• Worked with various SAS products SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS MACROS to develop required solutions.
• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis.
• Used PROC SORT, SET, UPDATE and MERGE statements for creating, updating and merging various SAS datasets.
• Validated data is processed based on the business rules. Used SORT, MERGE, SET statements and created final datasets for analysis.
• Provides load balancing for all SAS servers to improve output put and response time of all SAS clients.
• Analysed Phase II and III Clinical Trials.
• Developed and maintained programs in SAS using SAS tools for Windows and UNIX in a user support environment.
• Extensively used Base SAS MEANS, FREQ, and REPORT for summarization, cross-tabulations and statistical analysis purposes and SAS/GRAPH procedures like PROC GPLOT and PROC GCHART to generate reports.
• Conducted documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations 21CFR and other regulatory compliance
• Wrote programs using base SAS and SAS/Macros to extract data from oracle tables.
• Extracted raw data from warehouse and created SAS data sets that are required for the project analysis.
• Knowledge of CTMS, drug discovery and development, bioinformatics, ICH-GCP, drug protocol development, clinical trials, CDISC, SDTM, ADaM, clinical data management, CRF Design, EDC and Pharma covigilance.
• Involved in creating SAS datasets from flat files and EXCEL data as per requirement.
• Developed Edit check programs to clean invalid data from database.
• Generated tables, listings and graphs including patient’s demography and characteristics, adverse events, laboratory etc.
• Extensively used different SAS procedures such as PROC MEANS, PROC SORT, PROC FREQ, PROC COMPARE, PROC REPORT, PROC SQL, PROC GPLOT and Data NULL step and other statistical procedures.
• Collaborated with clinical researchers in the design of clinical trial selection of clinical endpoints, sample size requirements, protocol development, and Research and the Case Report Form design.
• Participated in writing of clinical trial reports and presenting of the trial results.

Environment: SAS/BASE, SAS STATS, SAS/BI, SAS/MACROS, SAS/MERGE, SAS Enterprise Guide, SAS/ODS.

Confidential, Cincinnati, OH

SAS Programmer

Responsibilities:

• Involved in creating specifications documents for SDTM and ADAM using annotated CRFs, SAP, mock-shells and Implementation guide.
• Created several domains in CDISC i.e., both SDTM and ADAM datasets on production side as well as validation side using specification.
• Good understanding of CDISC concepts and control terminology for SDTM IG 3.1.1 and 3.1.2 and ADAM IG 1.0 and 2.0.
• Worked as both production programmer and validation programmer in the process of creating Tables, Listings and Graphs.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Developed and customized reports using PROC REPORT, PROC SORT, PROC FREQ and PROC MEANS and DATA NULL.
• Created new datasets from existing data-sets by using concatenation, merging, interleaving and using conditional statements.
• Defining, Manipulation, Controlling and Reporting/Storage Query Language of Clinical Data by using PROC SQL.
• Created edit-check program and created clinical review listing for clinical team to review for data consistency.
• Involved in developing Kaplan-Maier Survival curves for comparison of event free survival rates using Proc Life test and Proc Gplot.
• Created ad hoc programs to provide information to the project team and/or client, as required.
• Imported data in the form of SAS datasets from flat files of various formats like tab delimited, .CSV, .XPT etc.
• Developed Macros to generate ad hoc reports weekly, monthly or on a specified cut date.
• Created various study specific macros by implementing debugging options.
• Created data quality listings to ensure data correctness and clinical review for clinical team.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, SDTM, CDISC, MS WINDOWS 2000 and UNIX.

Confidential, Deerfield IL

SAS Programmer

Responsibilities:

• Analysed three phases (I-III) of the Clinical Trials in different therapeutics areas.
• Developed SAS programs using SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT and SAS/GRAPH and for statistical analysis and data displays.
• Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format.
• Contributed to on-going preparation of SAS datasets for statistical analyses and demonstrations.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• In-depth knowledge of programming and reporting with Base SAS, SAS/STAT, SAS Language, SAS/ODS and Graph.
• Macros were written at various instances for automating listings and graphing of clinical data for analysis.
• Participated in edit check program development, testing and implementation when required by in house data management system.
• Generate reports either in HTML, PDF or RTF formats according to the client specifications.

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, Oracle, Windows.