Krithika R.

SAS Programmer

SUMMARY

SAS Programmer with 6+ years of experience in analysis, design, development, testing and implementation of various applications using SAS for interactive/dynamic reports generation in Pharmaceutical & CRO industry.

Broad Knowledge of Life Sciences with extensive experience in the clinical trial process (Phase I – IV).

Extensive experience in SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ASSIST, SAS/ODS, and SAS/SQL.

Experience using SAS with relational databases (Oracle and SQL Server) on Windows platform.

Excellent knowledge of SAS procedures like Proc Format, Proc Report, Proc Means, Proc Summary, Proc Freq, Proc Univariate, Proc SQL, Proc Import, and the _NULL_ data step.

Experience in providing Clinical Study Reports, compliant with 21 Code of Federal Regulations (21CFR) Part11.

Strong working knowledge of FDA regulations, ICH Guidelines, and GCP requirements.

Extensive knowledge of SAS/Graphs.

Working knowledge in the CDISC and MedDRA regulated environment.

Good working knowledge of all kinds of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials as per Statistical Analysis Plan (SAP)

Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spreadsheets, Microsoft Excel, and Oracle database.

Interacted with senior Bio-statisticians and clinical data managers to provide SAS programming in analyzing the data, generating reports, tables, listings and graphs.

Created RTF, PDF and HTML listings, tables and reports using SAS ODS.

Involved in pooling of data from multiple studies and generating Tables/Listings/Graphs for Summary of Clinical Safety (SCS) for FDA Submission.

SAS/Testing on clinical trials projects as per requirements, understanding of data and testing the date to meet the specifications accessing multiple databases.

Good in handling multiple projects at a time and large databases to perform complex data modifications.

Good technical and Analytical Skills and ability to work in a team as well as independently.

TECHNICAL SKILLS

SAS 9, R, SQL, Oracle, Windows/PC/UNIX, Unix shell scripting, Microsoft Office (Word, Excel, PPT), Notepad, Macro, DB2, Oracle Clinical Database, MS Access Database, MS SQL Database

PROFESSIONAL SUMMARY

Parexel, Waltham, MA Jun 2016-Till Date

SAS Clinical Consultant

Responsibilities:

Analyzed data, generated TLG’s and formatted HTML, RTF and PDF reports using SAS output delivery system ODS.

Created TFL’s using SAS Procedures: REPORT, SUMMARY, TRANSPOSE, UNIVARIATE, ANOVA, and MEANS.

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

Integrated reading in data from an external source into SAS datasets and creating appropriate reports.

Developed SAS programs using Base SAS for tabulation counts, correlations and check for dispersion for normality, sorting and merging data validations using PROC Means, PROC Tabulate and PROC Univariate.

Converted oracle data tables into SAS data files using SAS/SQL, converted SAS data files into transport files to be used in other system environments.

Create programs for presentation of graphs using SAS/GRAPH. The presentation of graphs include create a text slides, display several graphs at one time, combine graphs and text in one display and create automated presentations.

Environment: SAS/BASE, SAS/ACCESS, SAS/STAT, SAS/GRAPH, MS Excel

Azyme Biosciences, Bengaluru, India Aug 2012-May 2015

Clinical SAS Programmer

Responsibilities:

Generated analysis data sets for both safety and efficacy parameters based on the guidelines provided in the SAP (Statistical Analysis Plan).

Modified data sets using set, merging, sort, update, formats, and functions.

Validated datasets and TLGs by writing competing code.

Participation in Team meetings to discuss various issues.

Collected requirements from statisticians, prepared requirements document.

Developed macros for report generation using SAS/Macros as per the statistician’s requirements and programs for statistical analysis and data displays.

Documented the macros explaining the functionality of the macro and the macro parameters defined for future reference.

Prepared test plans and test runs for the respective program changed or created.

Used SAS ODS to create RTF and PDF reports.

Generated SAS/Graphs using standard macros.

Promoted developed code to production environment with proper documentation of changes made.

Participated in Program validation and e-submission (CDISC).

Used SAS functions, procedures, arrays, macros, formats extensively.

Environment: Base SAS v9, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, Windows, HTML, Macros, UNIX.

Molecular Connections, Bengaluru, India Jun 2011-Jul 2012 SAS Programmer

Responsibilities:

Created and applied user defined formats to specific variables in SAS data sets.

Developed SAS programs using SAS/BASE and SAS/SQL for preparing, analysis and reports from databases

Responsible for manipulating and analyzing clinical data, performing statistical analyses using

SAS, to generate tables, listings and graphs, and producing output files for use in reports or for use by physicians, statisticians and analytic staff.

Designed and developed reusable SAS code to prepare data for analysis

Provided secondary review of others output, and created and maintained necessary documentation

Engaged in the development of SAS programs, and other techniques to improve

efficiencies in reporting

Provided information and support for high-level internal and external audiences

Export SAS Results to Different Format, such as XML, Excel, RTF, PDF, PS, HTML by using SAS/EXPORT, SAS/ODS for Reporting and Presentation.

Environment: Base SAS, SAS Macros, SQL, HTML, XML, Windows NT, MS-Excel.

Polyclone Bioservices, Bengaluru, India Jan 2009-May 2011

SAS Programmer

Responsibilities:

Performed data analysis and statistical analysis using SAS/Base, SAS Macro and other procedures like Proc freq, Proc Univariate and Proc Means.

Reviewed protocols according to CDISC standards and Case Report Forms to identify irregular data entry errors of clinical trial data.

Created safety and efficacy customized reports, involved in creating transport files for electronic regulatory submissions to the FDA.

Effectively used many SAS functions like SCAN, SUBSTR, TRIM and applied strategic logic on data using INTCK, INTNX, SUM, SQRT, STD and VAR.

Used Dynamic Data Exchange and Proc Import for inputting data from Excel sheets.

Incorporated MedDRA terms for Adverse Event reporting. Performed Ad-hoc Programming in clinical trial reporting.

Generated primary and derived secondary SAS datasets, identified inconsistencies and problems in the database and reported the findings to the appropriate data management department personnel.

Effectively and timely contacted Project Manager of the respective studies about the various data issues and resolved the queries through meetings.

Ensured leadership in the planning and communication of clinical trials material (drug) needs for sponsored clinical studies.

Environment: Base SAS, SAS Macros, Oracle 8i, SQL, PL/SQL, UNIX, Windows NT, MS-Excel.

EDUCATION

Master of Analytics: Analytics (pursuing)

PhD: Chemistry (pursuing)

Master of Philosophy in Chemistry

Master of Science: Chemistry

Bachelor of Science: Chemistry

REFERENCES: Available on request

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