- 8+ years of SAS programming experience in Clinical trials (Phase1-III).
- Good knowledge in different phases (phase I to III) of the Clinical Trials.
- Worked with Senior Statisticians, Medical Writers and Project Managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs.
- Extensive experience in creating Analysis datasets, Tables, Listings and graphs.
- Created SDTM datasets (version 3.1.1) for Lab, AE, DM etc from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
- Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS-SQL, SAS ODS, SAS/GRAPH in Windows and UNIX environments
- Involved in the process of generating ISS/ISE reports for FDA submissions.
- Hands on Experience in creating SDTM and ADAM datasets by following CDISC standards.
- Good Experience in Statistical Analysis using SAS/STAT Procedures such asPROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, PROC GLM, PROC MIXEDetc.
- Experience with Data Validation, designing Edit check programs and parallel development of tables & listings for project level programs.
- Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
- Strong leadership ability to create, maintain and define strategies to improve the efficiency of running a clinical trial work effectively in a quality-focused environment.
- Very good experience on CDISC, SDTM and ADAM standards.
- Good Experience in Clinical Trials, Clinical Data Analysis, Generating Statistical Analysis Files, Tables, Documentation.
- Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data and Efficacy related data.
- Good knowledge in creating datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.
DOS, Windows 98/2000/XP,UNIX
MS Access, SQL, Oracle
SAS, C, C++, SQL,PL/SQL
SAS/Base, SAS/Stat, SAS/Graph, SAS/Access, SAS/Macro, SAS/Connect, SAS/SQL
Sr. SAS Programmer
Confidential, Wilmington, DelawareJune 2010–Till date
- Involved in QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
- Worked as a Lead programmer for Phase II studies.
- Involved in the Data mapping from Existing Raw data to CDISC SDTM Standard, data mapping from SDTM to ADAM domains and review CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.
- To ensure allotted CRF annotation is done and corresponding Peer QC is done with QC comments documented on tracking tool for each work request.
- To ensure the complete QC process and to develop & validate all clinical programs and are saved into UNIX respective to Project folders.
- Involved in validating and QC of the efficacy and safety tables.
- Created SAS programs for generating data listings for data review meetings.
- Involved in PK analysis like edit checks, PK tables and PK listings.
- Debugged and validated programs for logical/ syntax errors and applied formats and labels for compliance with CDISC guidelines.
- Produced TLG’s for Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).
- Generated output files in RTF, & PDF format using SAS ODS.
Sr. SAS Programmer
Confidential, Kansas Dec 2008– June 2010
- Analyzed phase II and phase III clinical trial data of the therapeutic areas- Oncology.
- Generated tables, listings and graphs as per the mock shells.
- Created specifications for developing SDTM datasets and Analysis datasets.
- Mapping and integrating study data to aCDISC-compliant proprietary analysis data system (SDTM 3.1.2).
- Table Programming for Integrated Summary of Efficacy (ISE) and Safety (ISS).
- Created Analysis data sets, Tables, Listings for ISS and ISE.
- Successfully engineered a streamlined end-to-end solution for CDSIC SDTM mapping from client’s raw data.
- Performed Level I and Level II Quality Control of SDTM datasets and analysis datasets (ADAM) in accordance with the company specifications.
- Experience in working with Data management team to resolve various data issues by providing edit check programs.
- Produced TLG’s from Integrated Summary of Safety (ISS) datasets.
- Used macros extensively and created few to ease the process of coding and to standardize programs.
- Provided statistical analysis of clinical trial data through SAS/STAT to the statisticians.
- Attended meetings with clinical research team along with statistician and project manager.
Confidential Genetics, WA July 2006 – Dec 2008
- Create datasets according to CDISC SDTM
- Responsible for providing SAS programming and analysis support for phase III clinical study.
- Created and maintained production programs for tables and listings for final submission to FDA.
- Created and maintained various validation programs for tables and listings.
- Used SAS Base Procedures PROC FREQ, PROC TABULATE and PROC MEANS to validate current results with expected results.
- Used SAS Macros for generating tables and listings.
- PROC REPORT, PROC TABULATE and DATA_NULL_ programming was used to generate the reports.
- Customized reports using PROC TABULATE, REPORT, SUMMARY and also provided descriptive statistics using Proc Means, Frequency, and Univariate.
- SAS GRAPH was used to generate the graphs.
- Developed Tables, Listings and Figures using PROC REPORT.
- Worked as a Lead programmer for Phase II study.
- Perform program documentation on all programs, files and variables for future reference.
- Interacted with statistician and clinical people for creating reports.
- Experience in providing tables and figures to be incorporated into Clinical Study Report along with patient data listings and technical statistical details such as derivations, computations, analyses etc and also involved in discussions with medical writers in the preparation of Clinical Study Report.
- Involved in validating and QC of the efficacy and safety tables and listings.
Confidential Aug 2004 – July 2006
- Involved in Phase II clinical trials
- Performed statistical analysis using SAS/Base, SAS Macro and other procedures like Proc freq, Proc Univariate and Proc Means.
- Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output
- Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL
- Created Safety and Efficacy customized reports for FDA regulatory submissions.
- Effectively used many SAS functions like SCAN, SUBSTR, and TRIM.
- Used Proc Import for importing data from Excel sheets and CSV files.
- Applied PROC SQL, PROC FREQ and PROC MEANS for data analysis and generated report using PROC TABULATE and PROC REPORT.
- Performed Ad-hoc Programming and Reporting.
- Generated Analysis datasets, identified inconsistencies and problems in the database and reported the findings to the appropriate data management department personnel.
Bachelors in pharmacy