Data Sas Programmer
Resume:
C linical SAS Programmer
Manju
acd7qz@r.postjobfree.com
Professional summary
• Over S ix years of experience in programming, analyzing and reporting in various
P harmaceutical, Biotech, and Healthcare using SAS on Windows environment.
• Hands on experience in working on p hase I-I V of Clinical t rials in
p harmaceutical/CRO organizations as a SAS programmer and a Statistical Analyst.
• Worked on various therapeutic areas such as Gastroenterology, Neurology, Cardiovascular and
Metabolic disorders Clinical Trials.
• Strong skills in working with SAS v8.2/v9.0 and BASE SAS, SAS/MACRO, SAS/STAT,
SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS.
• Extensive programming experience with P roc SQL, Proc Report, Proc Access, PROC
L I FETEST, Proc Gplot, Proc Sort, Proc Gchart, Proc Format, Proc Template, Proc
T ranspose, Proc Pr int, Proc Compare, P roc Append, Proc Import/Export, Proc P rint
t o, in formats and formats.
• Good understanding of Clinical T rial Phases, clinical protocols/ CRF’s/Annotated CRF’s,
G CP guidelines, NDA, I N D, CD ISC, MedDRA . Familiar with Electronic submission
guidelines to FDA
• Extensive experience with concatenating, interleaving, merging, sorting, printing and
reporting data in M S Excel and R TF format.
• Strong expertise in SAS Base procedures, Reporting and Summary procedures and experience
with PROC SQL, SAS DDE and SAS Arrays.
• Using ODS to generate HTML, PDF, RTF and LISTING output.
• Experience in CDISC, Study Data Tabulation Model (SDTM), and ADaM.
• Worked on FDA Submissions and have good knowledge of G CP guidelines.
• Exposure to clinical t r ial data such as demographic data, adverse events ( AE ), serious adverse
events (SAE ), laboratory data (lab data ) & v ital signs.
• Experience in Data Management tasks such as data extraction, data validation, data
manipulation, data processing, data transformation, data cleaning and data loading.
C linical SAS Programmer
• Effectively work as an individual contributor or a team member.
• Communicate and coordinate with internal and external stakeholders to resolve project
requirements and deadlines changes.
• Able to work independently and respond to t ight deadlines while displaying f lexibility
to ensure that team goals are met.
TECHN ICAL SKILS
Statistical Packages SAS
SAS Tools SASV8/9.1/9.2, SAS/BASE, SAS/MACROS, SAS/STAT,
SAS/GRAPHS, SAS/SQL, SAS/ACCESS, SAS/CONNECT
SAS/REPORTS, SAS/ODS.
Databases SQL server, Oracle and MS Access
Office Tools MS Word, Excel, Access, PowerPoint.
EDUCAT ION
• Master of Science in Pharmaceutical Science, Long Island University,New York, USA.
• Bachelor of Science in Pharmacy, Osmania University, Hyderabad,India.
PROFESSIONAL EXPER IENCE
M MS Holdings I nc ., C anton, M I F eb ‘12 –Till
C linical SAS Programmer
M MS Holdings Inc. is a clinical research organization that focuses on regulatory submission support for
t he pharmaceutical, biotech and medical device industries. Their core service areas include Biostatistics,
C linical Programming, Clinical Trial Disclosure and Oncology Data Abstraction. T he project involved
s tatistical analysis of Phase I I I Clinical Trial data extraction, analyzing, and reporting.
Responsibilities:
C linical SAS Programmer
• Provided SAS Programming and analysis support for p hase I I I (oncology) clinical t r ials.
• Performed D ata Cleaning and Validation using SAS data step and SAS procedures.
• Produced summaries and statistics using P ROC M EANS, PROC SUM MARY, PROC FREQ,
P ROC ANNOVA and P ROC UN IVAR IATE.
• Involved in Developing, D ebugging, and v alidating t he project-specific SAS programs to generate
derived SAS datasets, summary tables, and data listings according to departmental standards .
• Loaded SAS data sets as a table onto D B2 using SQL pass through facility, l ibrary reference
method .
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used
t ime to t ime and created tables, listing and graphical reports.
• Worked with C D ISC data models i ncluding S DTM, ADAM and ODM.
• Provided outputs for the C linical Study Report (CSR).
• Participated in monitoring C RO activities and reviewing CRO deliverable quality.
• Prepared new D atasets f rom raw data files using I mport Techniques and modified existing
datasets using Set, Merge, Sort, and U pdate, Formats, Functions and conditional statements.
• Created complex and reusable Macros and extensively used existing M acros and developed SAS
P rograms for D ata Cleaning, Validation, Analysis and Report generation. Tested and debugged
existing macros.
• Extensively used D ata _Null_ and SAS procedures such as P r int, Report, Tabulate, F req,
M eans, Summary and T ranspose for producing customized reports.
• Used SAS ODS t o create H T M L, RTF and P DF outputs files in the process of producing reports.
• Created C RTs w ith datasets in T ransport File Formats and D ata Definition Tables for N DA
submissions to F DA.
• Develop new or modify SAS p rograms to load data from the source and create study specific
datasets, which are used as source datasets for report generating programs.
• Cross-Validated SAS programs authored by other SAS programmers as a part of QA (Quality
Assurance)
• Used M S Excel t o produce spreadsheets with some statistical analysis for conformance to
generally acceptable standards for reproducibility of results and for validation of data generated in the
l ab work
C linical SAS Programmer
Environment: SAS/Base 9.1.3, SAS/Macros, SAS/STAT, SAS/Graph, SAS/ACCESS, SAS/ODS,
SAS/CONNECT, SAS/SQL, Oracle Clinical, Windows, MS-Excel, MS-PowerPoint, UN IX and Windows NT.
Wellcare, Tampa, FL J une’10 – Jan’12
C linical SAS Programmer
Responsibilities:
● E xtracted clinical t r ials data from the clinical data warehouse (Oracle), using SAS/ACCESS and
c reated SAS data sets.
● Reviewed company SOP’s, Case Report Forms and SAP of the clinical t r ials.
● E xtensively used SAS procedures l ike means, frequency and other statistical calculations for Data
validation.
● I ndependently programmed most macros, summary tables, listings, and all
documentations completed in compliance with Federal regulations and ICH
and GCP Guidelines.
● Worked with Medicaid and Medicare claims.
● P rogramming of SAS GU I applications using SAS/AF and SAS/FSP.
● I nvolved in wri ting code using SAS/BASE and SAS/MACROS to extract, clean and validate data from
oracle tables.
● M aintained C D ISC 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.
● E nables scheduling of production SAS workflows to be executed across grid resources.
● Uses all of the policies and resources of the grid.
C linical SAS Programmer
● A pplies grid policies to SAS workspace servers when they are launched through the grid..
● D esigned and created SAS datasets f rom various sources like Excel datasheets, f lat files and Oracle,
creating reports and files from existing SAS datasets.
● C reated survival graphs in Excel by t ransposing SAS datasets into Excel spreadsheets.
● I mplemented 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.
● I nvolved in the process of t ransferring and converting data from one platform to another for the future
use of different phases of clinical t rails.
● C reated r eports 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 P roc Anova, Proc Sort, Proc F req,
P roc Reg, Proc Univariate, P roc Cor r and presented results in histograms and box-plots.
● Assisted system analysts, data analysts, statisticians and medical wri ters.
Environment: SAS/BASE, SAS/MACRO, SAS/GRID, SAS/MERGE, SAS/ACCESS, SAS/SQL, SAS/STAT,
SAS/GRAPH, SAS/ODS, SPSS and MS EXCEL
S IROClinPha rm, Ewing, NJ J an
‘09 – May ‘10
C linical SAS Programmer
C linical SAS Programmer
SIRO ClinPharm is a Contract Research Organization involved in conducting Clinical Trials and
Data Management services to National and In ternational Pharmaceutical, Biotechnological
companies providing end-to-end solutions for data collections, Data Management and Data
A nalysis.
Responsibilities:
• Analysed the Clinical data for P hase I I and P hase I I I studies.
• Generated Tables, Listings and Graphs using various procedures like P ROC
M EANS,PROC F REQ, PROC TABU LATE, and P ROC GPLOT .
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study
reports and regulatory submissions.Successfully designed and implemented statistical
reporting processes.
• Performed Program Documentation on all programs, files and variables for accurate
h istorical record and for futurereference.
• Created SAS Macros and SAS Graphs. Used P ROC REPROT to generate reports.
• Review the P rotocol, Case Report Forms ( CRFs), and Statistical Analysis Plan (SAP)
and Develop programs to createTLG’s as per the SAP shell .
• Perform V alidation on Derived datasets, Tables and L istings following the SOPs and
document the same.
• Create Transport files using P ROC COPY and create the Define .pdf files for CRT’s.
• Created derived dataset’s Specification files for safety and efficacy data.
• Create and modify existing macros to meet the client needs.
• Database Creation and Table Programming for In tegrated Summaries of Efficacy ( ISE)
and Safety ( ISS) .
• Generated reports through O DS either in HTML, PDF or RTF formats according to the
client specifications and goodknowledge of CDISC standards.
• Created C D ISC SDT M domain data sets from existing clinical t r ial data to provide Case
Report Tabulation (CRT) data toa regulatory agency, such as the FDA and A Da M for
describing the full protocol of a clinical t rial.
Environment:SAS v9.3,SAS/Base, SAS/GRAPH, SAS/MACRO, SAS/SQL, SAS/ODS,
SAS/REPORT, W indows NT, MS Excel.
Sudershan biotech Ltd, Hyderabad, I ndia M ay ‘07 –
Dec ‘08
C linical SAS Programmer
Clinical SAS Programmer
Sudershan Biotech Limi ted (SBL) is a Research-Led Organization that started as a R&D unit specializing
i n Recombinant DNA technology, and thereby focusing on Industrial Enzymes, Diagnostic Proteins and
T herapeutic Proteins. The project involved statistical analysis of Phase I Clinical T rial data extraction,
analyzing, and reporting.
Responsibilities:
• Produced quality customized reports by using P ROC REPORT, SUM MARY and also provided
descriptive statistics using PROC Means, Frequency, and Univariate.
• Generated graphs using SAS/GRAPH and SAS Graphics Editor.
• Developed routine SAS macros according to the given specifications.
• Imported/Converted randomization data files from Excel, CSV data files into SAS data sets for
analysis.
• Designed f lowcharts indicating the input data sets and the techniques that would be used
(sorting, merging, etc.) to get the desired output.
• Wrote SAS code for data management and reporting, and performed validation, including testing
SAS code.
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated
C linical/Statistical reports.
ENV IRON MENT: SAS/BASE, SAS/STAT and Windows
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