MOHANA P

Senior Clinical SAS Programmer

Email: ad3yne@r.postjobfree.com

Contact: +1-516-***-****

Professional Summary

Certified SAS Programmer with 6+ years of experience in using SAS for programming and reporting in Pharmaceutical industry.

oStrong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/CDI and SAS/SQL in windows.

oExperience in transforming data in various formats (excel, CSV, ASCII) into SAS datasets.

Developed programs in SAS Base for converting the oracle Data into SAS datasets using SQL Pass through facility and library engines.

oExcellent command in producing reports employing various SAS procedures like Proc Report, Proc Tabulate, Proc Mean, Proc Freq, Proc Universe, Proc Transpose and Data Null etc.

oStrong experience using SAS/Graph to produce Graphs by employing SAS procedure such as Proc GPLOT and Proc GCHART.

oExceptional ability in problem solving, data analysis, complex reports generation with macro and data transfer between different environments.

oKnowledge of Clinical DATA Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models(ADaM).

oGood understanding of Clinical Trail Phases, clinical protocols/ CRF/ Annotated CRF’s, ICH and GCP guidelines, NDA, IND, MeDRA, 21 CFR PART11. Familiar with Electronic submission guidelines to FDA.

oExcellent communication, interpersonal skills with strong analytical and problem-solving skills. Ability to learn quickly and take up new tasks and responsibilities. Can work effectively in cross-functional environments.

oGood team player with excellent technical and interpersonal skills. Pro-active, self-motivated and able to work independently as well as in team.

oExperienced in producing RTF, PDF and MS Excel formatted files using SAS ODS facility.

oCreated SAS data sets and generated listings, Analysis Data Sets (ADS), Tables, Listings and Graphs (TLG) as per Statistical Analysis Plan (SAP), also performed validation of the CDISC Models.

oExperience in data cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.

o100% Project completion on time while meeting strict timelines and budget requirements.

TECHNICAL SKILLS

SAS Skills: BASE SAS, SAS/Enterprise Guide, SAS/MACRO, SAS/CONNECT, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/CDI.

SAS Procedures: TRANSPOSE, CONTENTS, MEANS, CHART, PLOT TABULATE, UNIVARIATE, SUMMARY, SORT, SQL FORMAT, FREQ AND DATASETS

Operating Systems: MS WINDOWS10/11, Linux.

Databases: ORACLE, SQL

PROFESSIONAL EXPERIENCE

Therapeutic Area: Oncology

Client: Ohio Department of Medicaid (ODM), Dallas, Tx April 2022-Present

Role: Sr. Clinical SAS Programmer

Responsibilities:

oApplied CDISC standards on clinical trial data for converting raw datasets to SDTM datasets with of mapping documents prepared by following SDTMIG.

oExperience in creating Analysis datasets model (ADaM).

oWorked in Phases of clinical trials for heart diseases and diabetes.

oDesigned and implemented statistical reporting processes for clinical data analysis.

oExtensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time and created tables, listings and graphical reports.

oGenerated output files in text format, HTML & PDF format using SAS ODS.

oCreated SAS transport (.xpt) files and converted the transport files into SAS Data sets.

oUsed SAS/ACCESS to extract data from Oracle and other relational databases for analysis.

oDeveloped flow charts indicating the input datasets and the techniques that would be used (sort, merge, append) to get the desired output.

oData Analysis and graphical presentation for various summary reports using Base SAS and SAS/Graph facility.

oCreated CRT(Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.

oPerformed data validation on the data sets and deleted repeated values using conditional data steps such as IF-THEN statements.

oGood working knowledge of Clinical Trials like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials.

oEstablished and maintained a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Databases personnel.

Environment: SAS/BASE, SAS/SQL, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ODS, ORACLE, Windows, Excel, SQL.

Therapeutic Area: Neurology

Client: EC Info Systems, Uniondale, NYC June 2019- Feb 2022

Role: SAS Programmer

Responsibilities:

oWorked where largely involved in safety and efficacy data analysis.

oImporting the data from Oracle database to SAS.

oReviewed and analyze source (raw) data and related study documentation under the supervision of a Manager.

oProvide different statistical analysis using descriptive statistics as per the requirements of project.

oExperience in developing, designing and or quality check CDISC/SDTM domains.

oInvolved in development and enhancement of SAS programmer and macros for analyzing data.

oDesign, develop, and modify SAS programs to store, analyze and evaluate data.

oGenerated different types of tables as per CDISC standards.

oCreated different types of summery tables and listings tables using PROC MEANS, PROC TABULATE, PROC REPORT.

oPerformed different type of data manipulation by MERGE, SET and PROC SQL.

oDevelop SAS macros for reusability and to minimize data processing period.

oInvolved in doing edit checks, validation of Analysis datasets, Tables & Listings. Involved in conversion of legacy data to CDISC/SDTM Datasets.

oExecute Quality Assurance procedures of other programmer’s work, cross-validation of SAS programs, and debug complex programming code by using DATA and PROC statement.

oCreated new datasets from raw data files Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.

oModified macros for report generation using SAS Macros as per the requirements.

oExtensively used Data Null and SAS procedures such as Print, Report, Tabulate, Freq, Means, Summary and Transpose for producing ad-hoc and customized reports and external files.

oRead raw data from a various business domains like Oracle, DB2, Excel, flat files into SAS.

oUsed LENGTH, INFORMAT to format variables and FORMAT, SPLIT to output data.

Environment: BASE SAS, SAS/GRAPH, SAS/STAT, SAS/MACRO, SAS/SQL, SAS/ACCESS, MS Excel, Windows, Oracle Clinical.

Therapeutic Area: Ophthalmology

Client: Omega Health Care, India Aug 2018 – May 2019

Role: Clinical SAS Programmer

Responsibilities:

oLoading the data from various sources into the system

oWorked with statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP) and departmental guidelines.

oCreated reports for online and batch applications for various servers.

oModified data using SAS/BASE and Macros.

oUnderstanding and using departmental utilities, processes and procedures where applicable.

oInvolved in publications, programming and testing of utility macros for standard reports validation.

oInvolved in analysis of Phase II and III clinical trials.

oCreated SDTM datasets and AdaM datasets according to CDISC standards.

oPrepared graphs using the modified data for business analysis.

oProduced Safety reports in PDF format.

oWorked with Data Management Team, investigating data issues and solving technical problems.

oAccuracy, completeness, quality, and timeliness of clinical programming deliverables.

oPerformed QC of derived datasets, TLG’s and coded programs and involved in Data Validation.

oPerformed program documentation on all program, files and variables for future.

oProgrammed all study-specific edit checks and review listings.

Environment: SAS 9.2 SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GTAPH, SAS/STAT, SAS/ACCESS, MS Excel/Word/PowerPoint

Client: Epi Source Pvt Ltd, India June 2017- Jul 2018

Role: Clinical SAS Programmer

Responsibilities:

oCreated, derived and pooled datasets, listings and summary tables.

oVerified the accuracy and integrity of data by performing validation checks written in SAS and investigate data related errors, outliers, and missing values.

oDeveloped and executed edit check programs according to specifications provided by data management operations for purposes of database verification.

oInvolved in managing phase II and III clinical trial data in the respective projects.

oUsed SAS SQL Pass through facility and Libname facility to import and create datasets from Oracle database.

oDeveloped and executed Proc SQL queries for merging, concatenating, and updating large volumes of data.

oUsed Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc.) and SAS/STAT procedures (REG, GLM, ANOVA, UNIVARIATE etc.) for summarization, Cross-Tabulations and statistical analysis purposes.

oCreated complex and reusable Macros for various instances for automating listings and graphing of data for analysis.

oDeveloped statistical reports by using Proc Report, Data null and SAS Macro.

oExecuted report programs and imported the results into Excel for data analysis.

oCreated ad-hoc reports using the SAS procedures and created reports using ODS statements and Proc Template to generate different output formats like pdf and excel.

oCreated SDTM datasets according to CDISC standards using Base SAS and validated using validator tools.

oCollaborated with Data Management to annotate raw data with standardized variables and formats using Proc Datasets, Proc Formats.

oPerformed data extraction from various repositories and pre-process data when applicable.

Environment: SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACRO, SAS/GRAPH, SAS/STAT, Windows.

Education:

Pharm D(Doctor of Pharmacy), Annamalai University,2017, India

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