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.
• Experienced in programming edit checks and patient profiles for Data management teams.
• Strong skills in working with SAS v8.2/v9.0 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.
• Involved in creating various SAS Reports satisfying the 21CFR-11 Code for Federal Regulations for electronic data submission.
• 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 analyzing the clinical trials and generating reports, tables, listings and graphs for internal purpose and for FDA according to the 21 CFR Part 11.
• 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.
• Experienced in working with graphs and annotating them using Proc gplot extensively.
• Knowledge of generating electronic deliverables submissions for Integrated Summaries ISE/ISS . 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.

SKILL SET:

PROFESSIONAL EXPERIENCE:

Confidential

Clinical SAS Programmer

Confidential Pharmaceuticals Company is a pharmaceutical company focused on discovering, licensing, developing and commercializing compounds in the endocrine, metabolic and cardiovascular therapeutic areas. The projects were on Phase II and Phase III clinical trials on endocrine therapeutic area. I worked as a clinical SAS programmer and the tasks included analysis of the clinical trials data, generating required reports, summaries and graphs for submission as per FDA and other regulatory requirements.

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.
• Analyzed 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, REPORT for summarization, cross-tabulations and statistical analysis purposes and SAS/GRAPH procedures like PROC GPLOT and PROC GCHART to generate reports.
• 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 Pharmacovigilance.
• 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 patients 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

Clinical SAS Programmer

Responsibilities:

• Involved in the support of Phase I, II, and III clinical trials for Oncology study.
• 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.
• Worked in the team preparing Integrated Summaries of Efficacy ISE and Safety ISS reports.
• 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

Clinical SAS Programmer

Responsibilities:

• Worked on Phase I, II III Clinical Trials data for various therapeutic areas.
• Worked on both CDISC and non-CDISC standard dataset as per client requirement and need. Created specification for the dataset programming.
• Created various analysis datasets from SDTM datasets and wrote some study specific macro for derivation of analysis variables.
• Worked with macro development team for modifying existing macros and creating new macros.
• Developed validated and documented programs to create TLG's Tables, Listings and Graphs as per Statistical Analysis Plan SAP using SAS reporting procedures like PROC REPORT, PROC SORT, Graphic procedures like PROC GPLOT and analysis procedures like PROC MEANS and PROC FREQ.
• Worked with SAS Scalable performance Data Server to reduce extraction, transformation and loading times, irrespective of data size.
• Provided flexible data storage options to support business intelligence and analytic application requirements using SAS Intelligence Storage according to the statistician's requirements to support different Phases in Clinical Trails.
• Worked on very strict timeline provided by client and created output with highest quality output as per client requirement.
• Performed Data analysis, generated Tables, listings and graphs as per requirement and based on mock up shell.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time and created tables, graphs and listing reports.
• Participated in weekly meetings and weekly priorities meetings to discuss the requirements and gather the client comments on the current study and set programming priorities.
• Involved in preparing the necessary documents metadata in define.xml, datasets in .xpt format required for regulatory submissions NDA .
• Performed Validation and QC of datasets, tables, listing and graphs.

Environment: SAS/BASE, SAS/STAT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/ACCESS, Excel, SQL, Windows 2000.

Confidential

Clinical SAS Programmer

Responsibilities:

• Worked mainly on phase I and II studies.
• Created edit check programs to investigate missing data, data anomalies in raw data sets and reported to DM.
• Developed programs to create SDTM domains, reviewed programs for quality check and used Proc Compare for QC check of the SDTM domains.
• Created Analysis Datasets from SDTM as per specifications and mock shells.
• Generated tables, listings and graphs for Clinical Study Reports in compliance with 21 CFR - Part 11, FDA, ICH, and GCP guidelines using PROC REPORT, PROC TABULATE and PROC GPLOT.
• Participated in Weekly Client Meetings and weekly priorities meetings to discuss the requirements and gather the client comments on the current study and set programming priorities.
• The programming of analysis databases derived datasets and transfers of data for internal and external clients and the programming of database quality control checks.
• Contributed to the development of standard operating procedures SOPs .

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/CONNECT, SAS/Access, SAS/MACRO, SAS/GRAPH, MS Access, Windows XP, Excel.