DR

Summary:
Expert level SAS Programmer with extensive Data Analysis and Statistical Analysis in Clinical
Development. Have good knowledge in Clinical Data Analysis and Clinical trial/ development process in
Pharmaceutical and Contract Research organizations.
Pharmaceutical Skills :
Over 7+ years of experience as a SAS Programmer on various platforms in Pharmaceutical and
manufacturing Companies.
Very good experience in Clinical Trials, Clinical Data Analysis, Generating Statistical Analysis
datasets, Tables, Listings, Graphs and Validations.
Strong skills in working with SAS [] and Base SAS, SAS/Macro, SAS/Stat, SAS/SQL,
SAS/Graph, SAS/ODS, and SAS/Access.
Extensive programming experience with Proc SQL, Proc Report, Proc Access, Proc Lifetest, Proc
Gplot, Proc Sort, Proc Gchart, Proc Format, Proc Template, Proc Transpose, Proc Print, Proc
Compare, Proc Append, Proc Import/Export, Proc Print to, in formats and formats.
Extensive experience in SAS/Stat procedures such as Proc Reg, Proc GLM, Proc Freq, Proc
Means and Proc Univariate.
Involved in creating various SAS Reports satisfying the 21CFR-11 (Code for Federal
Regulations) for electronic data submission.
Modified existing SAS programs and created new programs using SAS macros to improve ease
and speed of modification as well as consistency of results.
Experience in reporting Phase I to IV Clinical Trial Studies using reporting tool called HARP and
SAS(v9.1.3/v9.3).
Used the Harp / Utility macros/Standard macro to generate TLF and ADAM datasets
Creation of ADAM Specification for Datasets at HARP
Performed quality control (QC) on all process and technical activities related to derived datasets,
tables and listings.
Expertise In:
FDA Guidelines
Handling Clinical Data (Phase I-III)
Tables, Listings, and Summary Reports
Data Cleaning and Validation
Parallel Programming
Ad-Hoc Reporting
E-Submissions to FDA
GSKs HARP System
Technical Skills:
SAS Tools: SAS/BASE, SAS/ACCESS, SAS/SQL,
SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/REPORT, SAS/ODS.
Databases: Clinic-Trial, SQL server, PL/SQL Operating Systems: UNIX, Windows 98/2000/XP
Languages: SAS, SAS Enterprise Guide.

Office Tools: MS-OFFICE, Word, Excel, PowerPoint, HTML.

Core Competencies: Statistical programming, Clinical Trials, Data Analysis, Reports Development.
Professional Experience:
Clinical Programmer / Analyst
Responsibilities:
Extracted clinical trials data from the clinical data warehouse (Oracle), using SAS/Access and
created SAS data sets.
Reviewed company SOP's, Case Report Forms and SAP of the clinical trials.
Extensively used SAS procedures like means, frequency and other statistical calculations for
Data validation.
Independently programmed most macros, summary tables, listings, and all documentations
completed in compliance with Federal regulations and ICH and GCP Guidelines.
Programming of SAS GUI applications using SAS/AF and SAS/FSP.
Assisted system analysts, data analysts, statisticians and medical writers.
Involved in writing code using SAS/Base and SAS/Macros to extract, clean and validate data
from oracle tables.
Involved in development of CRT for Clinical trial analysis and Electronic submissions to FDA in
eCTD format.
Maintained CDISC SDTM and Adam standards Extensive experience with the SAS programming
and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including
thorough knowledge of SAS Macro Language.
Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS
Tools SAS/Base, SAS/Grid, SAS/Macros, SAS/Merge and SAS/Graph, SAS/SQL, SAS/Connect,
SAS/Access.
Enables scheduling of production SAS workflows to be executed across grid resources.
Uses all of the policies and resources of the grid.
Applies grid policies to SAS workspace servers when they are launched through the grid.
Data extraction from the Clinical databases and created SAS statistical analysis files for
regulatory submission to FDA approval.
Designed and created SAS datasets from various sources like Excel datasheets, flat files and
Oracle, creating reports and files from existing SAS datasets.
Reviewed and created electronic data and Clinical data for FDA and electronic submissions.
Created survival graphs in Excel by transposing SAS datasets into Excel spreadsheets.
Implemented data management principles, such as joining data set, indexing, data aggregation,
record selection, sub-setting, multiple records per case, creation and modification of views,
accessing multiple databases.
Involved in the process of transferring and converting data from one platform to another for the
future use of different phases of clinical trials.
Created reports using SAS/ODS and extensively used SAS/Arrays.
Developed SAS macros for data cleaning and reporting and to support route processing.
Performed statistical analysis using various procedures such as Proc Anova, Proc Sort, Proc
Freq, Proc Reg, Proc Univariate, Proc Corr and presented results in histograms and box-plots.
Environment:
SAS/Base, SAS/Macro, SAS/Grid, SAS/Merge, SAS/Access, SAS/SQL, SAS/Stat, SAS/Graph,
SAS/ODS, SPSS and MS Excel.

SAS Programmer/ Analyst

Created analysis data sets and SAS-generated outputs (tables, listings and graphs) validated
analysis datasets and SAS-generated outputs (tables, listings and graphs) via independent
programming.
Pooled data across multiple studies for ISS and ISE.
Updated MedDra versions of older studies to be consistent with newer studies when pooling data
across multiple studies.
Involved in generating TLGs for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA
submission.
Resolved issues with datasets, tables and listings to the satisfaction of lead and senior
biostatisticians.
Communicated with Statisticians about various analysis dataset and TLG specification related
Issues.
Implemented CDISC SDTM standard for raw data.
Created transport files for Submission.
Created Adam datasets.
Managed the clinical trial project (organize timelines, responsibilities and deliverables).
Performed programming for internal and FDA ad hoc requests.
Handled Dropouts and Missing Data by using traditional approach of generating LastObservation-Carried-Forward (LOCF) data on Visit-wise data.
Developed Macros to replace repetitive codes for generating Descriptive statistics.
Developed efficient, well-documented, readily comprehensible and modifiable SAS code using
SAS/ Base and SAS/ Macro facility.
Worked on producing datasets, tables, and listings using GSK standard macros.
Performed quality control (QC) on all process and technical activities related to derived
Datasets, tables and listings.
Generated listings using SAS procedures.
Involved in Black Box validation of analysis datasets, tables, listings and graphs using various
SAS skills, user defined macros and SQL procedures.
Worked on Pk (Pharmacokinetic) Concentration and PD (Pharmcodynamic).
Mainly validated pkconc datasets, PD datasets, pkconc tables, Pd tables, pkconc listings, Pd
listings and pk parameters listings.
Maintained and updated existing utilities as per project requirements.
Used department macros for report generation.
Built complete format libraries for various studies.
Active involvement in knowledge sharing via presentations at monthly programming meetings.
SAS Programmer
The project was a multi-centre, randomized, double-blind, placebo-controlled, one way cross
over, multi dose, safety and efficacy study of investigational drug administrated intravenously in
subjects with active moderate to severe psoriasis.
Developed new or modified SAS programs to load data from the source and create study specific
datasets
Generated various clinical reports, tables and developed data entry validation programs and
Collected and analyzed data from data sources to develop a comprehensive baseline report on
the identifiable factors driving up the healthcare cost such as: smoking, diabetes, back pain, or
other chronic conditions.
Created reports and assigned engagement levels to employee wellness programs.
Created SAS customized reports, listing and graphs for regulatory submissions using procedure
like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, ANOVA, CORR,
GPLOT and GCHART.

Worked on data analysis, statistical analysis and generated reports, listings and graphs
using BASE SAS and SAS STAT, SAS GRAPH, SAS SQL and SAS ODS
Extensively used SAS MACRO facility to provide reusable programs that can be
conveniently used time to time and created tables, graphs and listing reports.
Prepared/reviewed protocol documents, statistical analysis plans extensively analyzed
intervention effectiveness.
Consistently ran programs checks from wellness survey data in order to determine need for
extension, termination or adjusting and cost-effective analysis Involved in preparation of ISS
and ISE reports.
Delivered accurate and consistent analysis in a common format that enables departments
and executives to gain insights into complicated data.
Established and maintained sound working relationship and effective communication
Environment: Base SAS, SAS/ACCESS, SAS/CONNECT, SAS/STAT, SAS/GRAPH,
SAS/SQL, SAS/ODS, SAS/MACROS, MS Access, Windows.

SAS Programmer/Analyst

Created the designated Tables, Figures, and Listings according to the Statistical Analysis
Plan (SAP) and following the directive of the Programming Manager.
Performed verification of SAS-generated outputs (tables, listings and graphs) via
independent programming.
Reviewed mock-up tables, listings, analysis datasets specifications and provided feedback to
statistician.
Integrated data from multiple studies for ISS and ISE.
Implemented CDISC SDTM Standards.
Involved in creating Transport-files for electronic submissions to FDA.
Performed ad hoc programming as per clients requests.
Produced high quality graphs through SAS/GRAPH for analysis.
Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical
study reports and regulatory submissions and maintained existing ones.
Team in the design and implementation of analysis and programming of reports used for
analyzing clinical trials data.
Assisted Manager of Programming by validating, researching, and implementing new
software and programming processes.
Assisted with development, implementation, maintenance, and user support of programming
tools and process methodology within the Statistical Programming department.

SAS Programmer/ Analyst

Produced data listings, summary tables and graphics for interim and final analysis and
publications.
Provided data in SAS transport files, and other appropriate deliverables and documentation
for regulatory submissions.
Performed validation programming on clinical trial data using SAS MACROS.
Created base macros to run reports.
Creating standard reports to use across studies and creating base programs to set up data.
Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and
graphs.
Produced ADHOC reports for presentation and further analysis.
Performed quality controls (QC) on SAS programs.
Study: Worked on a number of Oncology Phase1 studies as a Programmer/Analyst.
Generated tables and summary statistics using PROC REPORT, PROC SUMMARY, PROC
MEANS, PROC UNIVARIATE, PROC FREQ other SAS techniques, statistical procedures,

various user defined macros and SQL procedures.

SAS programmer
Worked on producing datasets, tables, and listings using GSK standard macros.
Performed quality control (QC) on all process and technical activities related to derived
datasets, tables and listings.
Generated listings using SAS procedures.
Involved in Black Box validation of analysis datasets, tables, listings and graphs using
various SAS skills, user defined macros and SQL procedures.
Worked on Pk (Pharmacokinetic) Concentration and PD (Pharmcodynamic).
Mainly validated pkconc datasets, PD datasets, pkconc tables, Pd tables, pkconc listings, Pd
listings and pk parameters listings.
Generated Lab datasets using CDISC standards and also validated Lab datasets.
Worked on data cleaning on raw datasets delivered from data management team.
Involved in e-submissions, submitted data tabulations in SDTM standard format, data
listings, analysis datasets, Metadata, Annotated CRF, subject profiles and creating define.
PDF document following CDISC standards.
Documented all project data flows and programs.
Responsible for implementing and monitoring clinical research trials, tracking study progress
and ensuring data integrity.