Certified SAS Programmer with 5 plus years of experience as SAS Programmer Analyst in the Pharmaceutical industry.
Strong experience in Statistical Analysis, Reporting, and Regulatory defense.
Extensive experience in using various SAS products including SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACRO, and SAS/SQL in Unix and Windows environments.
Thorough knowledge of drug development process from initial submission in Clinical Trial Phases (I-III) including developing annotated Case Report Forms (CRFs), Data Definition Table (DDT) and preparation of Case Report Tabulations (CRT) in compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, SDTM and ADaM.
Having experience in creating and validating integrated datasets and TLF programming for ISS (Integrated Summary of Safety) and FDA requests.
Worked with statisticians to provide SAS programming support in performing safety and efficacy analysis, generating and validating analysis datasets, tables, listings and graphs for FDA submissions such as NDA.
Worked with SAS Procedures such as PROC SORT, PROC TRANSPOSE, PROC MERGE, PROC MEANS, PROC PRINT, PROC REPORT to produce safety outputs
Used statistical procedures such as PROC GLM, PROC MIXED, PROC TTEST, NPRA1WAY, PROC LIFE TEST and PROC ANOVA to prepare various efficacy tables in RTF formats
Ability to create, maintain and define strategies to improve the efficiency of SAS programming in clinical trials such as using SAS/Macros.
Created RTF, PDF and HTML listings, tables and reports using SAS ODS.
Used Macro Facility in the generation of Statistical Reports, Ad-hoc reports and Data Cleaning.
Experience in various therapeutic areas such as CVS, Dental, Dermatology, Anti-infective, Immunology, Arthritis and CNS.
Create standard macros and applications to improve the efficiency of SAS programming in the statistical programming department. Write some common macros that are useful across multiple studies.
Provided programming support for regulatory submissions and requests from agency on post submission activities.
Excellent exposure to FDA and ICH regulations applicable to the design, analysis and reporting of
clinical trials. Good knowledge of coding dictionaries such as MedDRA, WHODRUG.
Languages : SAS, C, C++, SQL, PL/SQL
Database : MS Access, SQL SERVER, Oracle Clinical.
Application Software : MS Office, SAS, SPSS.
Operating Systems : Windows, UNIX
SAS TOOLS : SAS/Base, SAS/Stat, SAS/Access, SAS/Macro. SAS/EG
Bachelor of Computer Science in K L University, Guntur, India. Apr’ 2012
Senior SAS Programmer:
MMS Holdings, Canton, MI (Jan ‘16 - Till Date)
Develop specifications for database in CDISC format, Program datasets in SDTM format and manage CDISC database for several studies.
Create and validate analysis data sets, tables and listings for high priority requests.
Develop Tables, Listings and Figures according to statistical analysis plans (SAP).
Perform validation on derived datasets and following the standard operating procedures during validation process.
Involve in multiple projects and interacted with other SAS programmers, statisticians and data managers to analyze data.
Provide SAS programming support for phase I, II and III clinical studies. Created lab shift tables, Demog, AE, Vital signs, Conmed, and efficacy tables and listings.
Generate various Efficacy and Safety Tables for several studies
Involve in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) for ISR (Integrated summary report) to compare and to differentiate all other study results and to get conclusion after reviewing the patient benefit/risk profile of drug.
Create transport files for electronic submissions to FDA
Extensively used SAS procedures including Proc Lifetest and generated Kaplan-Meier curves to estimate the survival probability of cancer patients for different treatments.
Extensively used dataset merging techniques, macro facility, Proc report, SAS functions, and SAS formats.
Involved in standardizing reporting procedures for graphical and tabular reports
Managed deliverables against aggressive timelines.
Covance, Madison, WI (Dec’12 – Nov’15)
Developed SDTM and ADaM datasets for various on-going studies.
Developed and maintained the programs to meet internal and external clients' needs.
Produced Top line efficacy results and creating analysis dataset for these efficacy results as per the specifications of client
Created ad-hoc reports using SAS
Programmed edit checks to satisfy data collection, storage, and analysis for clinical studies.
Responsible for providing proper validation, including testing and documentation in accordance with company standards.
Participated in the design and maintenance of a standard programming environment.
Used SAS Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
Developed, maintained and utilized standard SAS naming conventions for macro library supporting consistency and reusability of programs.
Retrieved the data from flat files, oracle database with the SQL pass-through facility and
created SAS data sets for Analysis.
Generated tables, listings and graphs as well as integrated summary of safety (ISS) and integrated summary of efficacy (ISE) reports for onward submission to FDA.
Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.
Extensively interacted with the functional users to understand the requirements on statistical methods and measures.