Clinical SAS Programmer with over 9+ years of experience in the Pharmaceutical and CRO.
Thorough knowledge of the drug development process with strong experience of analyzing and reporting in all the phases of clinical trials (I - III). Extensive programming experience in generating Analysis Datasets by using company standards.
Created specifications for CDISC SDTM, ADaM and Analysis Datasets by using company standards. Extensive work experience in creating CDISC SDTM and ADaM datasets.
Worked with different clinical trials data like DM, DS, Adverse Event (AE), QS, LB,VS, MH etc.
Knowledge of Life Sciences with extensive experience in the clinical trial processes and their designs including open-labeled, single blinded, double blinded, randomized and crossover studies.
Extensive experience in SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODSSAS/STAT, SAS/SQL in Windows and UNIX environments.
Extensive experience in Data extraction, transformations, analysis and generation of Tables, Listings, Graphs/Figures (TFLs) and Summaries, according to Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP’s) and departmental guidelines. Experience in producing reports using various SAS procedures like Proc Print, Proc Report, Proc GLM, Proc ANOVA, Proc Mean, Proc FREQ and Proc Univariate.
Good understanding of Clinical Trial Protocol and CRF annotation and participated in review of Protocols, CRF’s and Statistical Analysis Plan(SAP).
Experience in Producing RTF, HTML and PDF formatted files using SAS/ODS. Involved in the process of generating Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission.
Excellent leadership, analytical and problem-solving quality with excellent presentation skills.
Dedicated, hardworking individual with intercommunication skills to work at all levels of the organization.
SAS Tools: SAS V9.2, V9.1.3, Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS.
Operating System: Windows 95/2000, Windows NT, MS DOS, UNIX, Sun Solaris.
Databases: Oracle 7.x/8, Oracle Clinical.
Packages: MS Office 97/2000/2007, WordPerfect, Excel 97/2000/2007/2010
Bachelor of Computer Science, from New York Institute of Technology, NY, USA.
Algo Pharma, TX Jan 2015 – Till Date
Sr. SAS programmer
Created and used SAS Macros (local and global Macros) to generate the tables, reports, graphs, and listings.
Worked as a SAS Programmer with Bio-statisticians for Phase II & III clinical trials.
Programming analysis datasets in SDTM & ADaM model by using with them created Table, Listings and Figures.
Utilized Pinnacle 21 to check compliance for SDTM, ADaM and Define.xml.
Created and used utility Macros for SDTM and ADaM data sets to produce TLFs and validating the tables.
Developed specifications for database in CDISC format and involved in programming datasets in CDISC format (STDM & ADaM) and managed CDISC database for several studies.
Used existing Macros to produce datasets and displays and produced macros for validation. Extensively worked on CDISC ISS, integrating different study protocols for the analysis of drug effects on subjects.
Developed mapping Macros for SDTM and ADaM data sets. Worked on Ad-hoc requests for various studies in different therapeutic areas and provided programming support to the projects.
Used study specific Macros in therapeutic areas like Oncology and CNS which were provided by companies to create summary tables for safety and intent to treatment (ITT) populations.
Developed Integrated Analysis of Safety & Efficacy – ISS & ISE and worked on INDs & NDAs submissions.
Based on the Clinical Trials Protocol and guidelines, the data is analyzed using SAS Statistical procedures such as Proc means, Proc Univariate, Proc GLM, Proc Reg, Proc test and created output datasets.
Syneos Health, TX May 2012 – Dec 2014
Performed data mapping from CDISC data sets to STDM and data mapping from STDM to Adam standards.
Generated tables and listings for Adverse Events, Vital signs, clinical laboratory evaluations, disposition of subjects, concomitant medications and protocol violations.
Generated summary tables, graphs and data listings for interim and final analysis on clinical data.
Worked as a validation programmer at protocol level for setup programs.
Generated output in various formatted files such as Excel sheets, RTF and PDF using SAS/ODS.
Experience in creating user friendly macros and replacing the code with macros to reduce code redundancy.
Worked with Bio statistician to analyze the results obtained from various statistical procedures like proc ANOVA, GLM and T test. Resolved requests issued from the study teams on SDTM domains.
Enhanced existing SAS programs and created new programs using SAS Macro variables to improve ease and speed of modification as well as consistency of results.
Produced TLG’s for Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).
Performed QC, Data validation and edit checks using various procedures and SAS macro facility.
Generated Ad hoc Listings to Data Management in the form of .rtf files, as per the request.
Created datasets, reports, summaries using Proc SUMMARY, Proc REPORT, Proc UNIVARIATE and Proc TABULATE.
Assisted statisticians in generating frequency distributions and to present the results in histograms, box-plots, pie-chart and scatter-plots using the graphical procedures.
Icon PLC., TX Apr 2009 – Apr 2012
Developed Specifications for analysis datasets as per company standards.
Generated tables, listings and graphs with the help of SAS/BASE, SAS/STAT and SAS/SQL in Windows environment. Independently investigating data issues and solving technically complex problems.
Worked on phase I, II Cardiovascular studies and Oncology Trails.
Involved in creating specifications documents for SDTM and ADaM using annotated CRFs, SAP, mock-shells and Implementation guide.
Performed validation on derived datasets by following the SOP during the validation process.
Generated analysis datasets with derived variables and performed statistical analysis on data as per the requirements in the SAP and Protocol.
Developed and Validated SAS programs and macro codes to produce analysis datasets and reports including non-standard ad-hoc requests.
Performed QC of derived datasets, TLG’s and coded programs and involved in Data Validation. Produced Safety and Efficacy reports in RTF format.
Create datasets according to CDISC SDTM standards.
Participated in supervision of data entry operations under the guidance of Data Manager.
Used procedures such as PROC MEANS, PROC UNIVARIATE, PROC FREQ and used several functions.
Converted Raw data to SDTM compliant. Performed ad-hoc programming as per client’s requests.