SAS Programmer

Jasmeet K

E-mail: *******@*****.***

SUMMARY

 SAS Institute Certified BASE SAS® Programmer

 Over two years of experience in analysis, design, and development of applications, reporting and modeling in SAS programming.

 Good knowledge in different phases (phase I to IV) of clinical trials.

 Good working knowledge of clinical trials data like Demographic, Adverse Events, Laboratory data, Vital Signs etc.

 Good knowledge and experience in using various SAS tools like SAS/BASE, SAS/ODS, SAS/SQL SAS/MACROS, SAS/STAT, SAS/GRAPH and SAS/ACCESS.

 Generated TLGs (Tables, Listings and Graphs) for different phases of clinical trials for FDA submission.

 Thorough knowledge in importing and exporting raw data files in different formats (excel, comma, tab etc).

 Good experience in using SAS ODS to produce HTML, RTF and PDF outputs.

 Created SAS Transport files (.xpt) for submission purposes.

 Knowledge of ISS (Integrated Summaries of Efficacy) and ISE (Integrated Summaries of Safety) as per specifications.

 Good experience in SAS procedures like FREQ, SORT, COMPARE, TABULATE, SQL and MEANS to validate current results with expected results.

 Familiar with FDA/GCP/ICH computer systems validation guidelines and electronic records/signature regulations, 21 CFR Part 11.

 Good experience in documentation and annotation of CRFs according to protocol.

 Knowledge of CDISC SDTM V3.1 standard datasets and ADaM datasets.

 Experience in Ad-hoc Programming for clinical and data management departments.

 Knowledge in creating CRT datasets from clinical trial data, CDISC and MEDRA for regulatory submissions.

 Good experience in PK/PD (Pharmacokinetic/Pharmacodynamic) programming for Phase I clinical trials.

 Good experience in Data Validation and Data Cleaning on clinical trial data using statistical procedures like PROC FREQ, PROC MEANS and PROC UNIVARIATE.

 Good knowledge in using various SAS GRAPH procedures like PROC PLOT, PROC GPLOT, PROC GCHART.

 Highly skilful in using SAS on UNIX and Windows environment.

 Very good analytical problem solving and interpersonal skills.

 Always keen to learn something new and has emerged as an excellent team member.

TECHNICAL SKILLS

SAS Skills: SAS V8.2 SAS 9.1, BASE SAS, SAS Macros, SAS graph, SAS

Stat, SAS SQL, SAS ODS.

Programming languages: C, UNIX Scripting.

Operating Systems: Windows 98-2003/NT/XP/VISTA, UNIX.

PROFESSIONAL EXPERIENCE

GLAXOSMITHKLINE, PA SAS PROGRAMMER Sept 09 –till Date

RESPONSIBILITIES

 Performed Data Analysis, statistical analysis, generated reports, listings and graphs using SAS Base, SAS Macros, SAS Graph, SAS SQL.

 Successfully created Ad-Hoc PDF and RTF reports using SAS/ODS.

 Used reporting tools such as data_null_ and proc report to create SAS customized reports for FDA evaluation.

 Retrieved tables from Oracle Clinical databases using SQL Pass through Facility.

 Extensively used Last Observation Carry Forward (LOCF) method to handle missing values.

 Performed Data Validation to meet SAP requirements.

 Created Analysis Datasets from clinical data as well as CDISC/SDTM specifications.

 Created desired reports and summaries using PROC REPORT, PROC SUMMARY AND PROC TABULATE.

 Provided descriptive statistics using PROC MEANS, PROC FREQ and PROC UNIVARIATE.

 Always performed Program Documentation on all programs for future references.

 Involved in the analysis of Phase II and III clinical trials.

 Created Define.xml like Variable Metadata, Value-level Metadata and Control Terminology.

 Extensively used SAS/Macros to provide reusable programs that can be used for future purposes.

 Involved in generating ISS(Integrated Summary of Safety) and ISE(Integrated Summary of Efficacy) analysis datasets, Tables, Listing and Graphs for multiple trials.

 Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.

 Reviewed Protocols, Case Report Forms, Statistical Analysis Plans for Clinical Trials.

 Knowledge of data extraction into SAS using EDC tool.

 Worked together with biostatisticians to develop clinical trial reporting systems, tables, patient listings and case report tabulations.

 Involved in validation of derived datasets and other coded programs using PROC COMPARE.

ONYX PHARMACEUTICALS, CA SEP’ 08 – AUG’ 09

CLINICAL SAS ANALYST

RESPONSIBILITIES:

 Used SAS/Base, SAS/SQL procedures and provided programming expertise for employees and sponsors as needed.

 Used SQL procedures to replace complex merge statements.

 Reviewed Protocols, Case Report Forms and Statistical Analysis Plans for Clinical Trials.

 Assisted in the analysis of Phase I and Phase II clinical studies.

 Used pre-existing Macros wherever needed to decrease the code length.

 Debugged macros and regular programs to ensure cleanliness of log.

 Assisted data management team in preparing case report forms for clinical study.

 Used basic set, merge, update statements to create new datasets from existing datasets to meet requirements.

 Used several numeric and character functions in SAS programs.

 Created datasets from raw data files (Excel, CSV etc) and Oracle SQL related files.

 Assisted Senior Programmer in generating Tables, Listings and Graphs.

 Used SAS/GRAPH Procedures like Proc Gchart and Proc Gplot.

 Attended several meetings with Senior Programmer and Statistician.

EDUCATION:

MS – Masters in Biological Sciences with concentration in Statistics, USA

BS - Bachelors in Bio Medical Engineering, JNTU, INDIA.

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