Resume of SRAVANTHI
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Resume of SRAVANTHI
SUMMARY OF QUALIFICATIONS:
• Certified Statistical SAS Base Programmer with overall experience of FIVE years working with SAS and SAS tools emphasizing on analysis, program development, QC and validation in life science and healthcare industries on Windows and UNIX environment. Familiar with Chem-Draw and Drug designing software Discovery Studio.
• Have good knowledge and hands on experience in pre-clinical and clinical data collection, worked on Assay of Glycosylated Hemoglobin and C – reactive protein levels in Diabetic patient’s blood in India. Worked on Protein modeling and drug designing software
• Extensive experience with clinical data analysis: analyzing clinical data, creating tables, listing and generating reports and graphs.
• Performed data validation and developed study specific edit checks specifications. Used statistical procedures like Proc freq, means and univariate and compare.
• Created Ad-hoc reports before the Database Lock (DBL).Created Ad-hoc reports and summary reports using report and tabulate procedures.
• Familiar with the creation of .XPT files (transport files), DDF files (Data definition) for E-submission
• Good working knowledge on manipulation procedures like PROC transpose, append, datasets
• Created safety and efficacy Analysis/Derived Data sets from raw data sets. Experience in creating analysis datasets for various raw datasets
• Created transport files for CRO’S/Sponsors Submission using procedures Cport and Cimport
• Worked with the team in validating the ISS and ISE datasets and preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports. Created HTML, PDF and RTF reports using SAS Output Delivery System (ODS).
• Good working knowledge of clinical trials data like Demographic (DM), Adverse Events (AE), Serious Adverse Events (SAE), Laboratory Data (LAB Data), PK parameters.
• Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs.
• Created NONMEM datasets Population Pharmacokinetic (PK) and Exposure Response (ER) from analysis datasets and derived the variables.
• Experience in configuring PROC CDISC in SAS version 9.0, familiar with CDISC SDTM model, domains (Events, Findings, Intervention, and Special Purpose) and Open CDISC for validation. Modified the code and created CDISC compliant datasets.
• Worked on GAP analysis and Mapping to meet SDTM standards using open CDISC Validation tool.
• Exceptional problem solving skills for delivering useful and prudent solution. Excellent written and communication skills, good team player and always open to learn.
Certifications:
• Certified Base Programmer SAS 9.0.
• Chem draw & Drug designing software Discovery Studio 2.5 (Accelrys).
TECHNICAL SKILLS:
Operating Systems: Windows 98/XP/2000/2003/Windows 8.
Database Platforms: Clin-Trial, MS ACCESS, ORACLE Clinical.
Statistical Software: SAS / BASE, SAS / STAT, SAS / SQL, SAS / MACRO, SAS / GRAPH, SAS / CONNECT, SAS / ACCESS.
Software Packages: MS-Office (Word, Excel, Power point).
Programming Tools: SAS, SAS Enterprise Guide, SAS Viewer/Universal, SQL, SAS ERROR Log, Open CDISC Validator.
PROFESSIONAL EXPERIENCE:
Nostrum Pharmaceuticals INC, NJ Jan 13 - Present
Statistical SAS Programmer
First in human assessment of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of drug in healthy subjects and in patients with type 2 diabetes mellitus, if tolerated and effective in healthy subjects.
Responsibilities:
• Worked on Clinical Trials data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (LB), Physical Examination (PE) and vital signs (VS).
• Reviewed clinical study protocol, case report form (CRF), annotated the CRF and provided comments for electronic CRF (eCRF).
• Validated the edit check program and the reports for quality control process.
• Reviewed statistical analysis plan, mock-up’s/shells/templates, provided comments as needed.
• Familiar with updating mock-up as per new study design.
• Referring the statistical analysis plan (SAP), analysis dataset specification was developed and developed analysis dataset programs.
• Validated and maintained status on quality control document for the team, validation has been performed as specified in the QC tracking sheet.
• Generated safety, efficacy, and graphs as mentioned in the template and validated as per the QC tracking sheet, used SAS Output Delivery system (ODS) for generating reports in specific output formats like RTF, PDF, and HTML.
• Used, customized, developed company/therapy/study level macros for generating tables, listings, graphs.
• Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Converting the analyzed datasets into transport (.XPT) and data definition documents (DDD) files for e-submission to FDA.
• Performed the GAP analysis and Mapping data with the target data following CDISC standards (SDTM Version 3.1 & implementation guide).
• Familiar with different classes and several domains related to CDISC SDTM standards.
Environment: SAS 8/9, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/ODS, Excel/Access 2000, UNIX.
Rppmed Inc, FL Jan 12 - Nov 12
Clinical SAS Programmer
AERS:
Responsibilities:
Responsible for extracting the data from ASCII files to SAS dataset using import procedures
• Worked on AERS data like Demographic data, Drug, Therapy.
• Reviewed statistical analysis plan, mock-up’s/shells/templates.
• Referring the statistical analysis plan (SAP), analysis datasets were developed.
• Validated and maintained status on quality control document for the team, validation has been performed as specified in the QC tracking sheet.
• Generated AD-hoc reports for several important datasets for the medical team.
• Managed the existing database and continuously updated with new AERS data as made available by FDA.
• Generated tables, listings and graphs as mentioned in the template using PROC report, PROC tabulate.
• Validated the generated TLG’s accordingly to the QC tracking sheet.
• Used SAS Output Delivery system (ODS) for generating reports in specific output formats like RTF, PDF, and HTML.
• Used and customized company/therapy/study level macros for generating tables, listings, graphs.
• Converted the analyzed datasets into transport (.XPT) and data definition documents (DDD) files for e-submission to FDA.
• Performed the GAP analysis and Mapping data with the target data following CDISC standards
• Familiar with different classes and several domains related to CDISC SDTM standards.
Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/ODS, Excel/Access 2000, UNIX.
Symmetrix Pharmaceuticals Inc, NJ Oct 11 - Dec 11
SAS Programmer
Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells in patients with Stable Ischemic Stroke.
Responsibilities:
• Worked on clinical data like Demographic data (DM), Lab data (LB), Vital signs (VS), Adverse events (AE), Pharmacokinetic concentrations (PC).
• Annotated CRT’s (Case Report Tabulations) and Templates.
• Created edit check specifications and documented them.
• Validated the edit check program and the reports for quality control process.
• Generated AD-hoc reports using print procedure.
• Generated reports, listings and graphs according to the template provided using PROC tabulate, PROC report, PROC Gplot.
• Validated the generated reports according to QC tracking sheet.
• Using SAS Output Delivery system (ODS), generated reports in specific output formats like RTF, PDF, and HTML.
• Debugging and correcting the syntax and semantic errors in the code.
Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/ODS, Excel/Access 2000, UNIX.
GVK Biosciences, India Aug 08 - Sep 11
Research associate in Bio-informatics
Responsibilities:
• Responsible for extracting the data, cleaning, manipulating, transferring and managing data in SAS.
• Experience in entering, analyzing and coordinating data, generating tables, listings, graphs, and reports.
• Extracted data from Oracle table, performed quality checks, validated the data, and created SAS datasets. Modifying data using SAS code by importing, sorting, merging, and restructuring.
• Analyzing the data sets, Generating statistical reports using PROC tabulate, PROC report
• Experience in data transformation and edit checks and experience in analyzing Case Report Form data.
• Worked with clinical data management team for creating annotated CRF. Created new analysis data sets from raw data sets for clinical trials
• Performed quality checks on the existing table, listing and figures, Tested and debugged SAS programs against data.
• Produced Ad-hoc reports, listings, tables, TLGs using Proc report, Proc tabulate, Proc gplot etc.
• Involved in preparing the necessary documents (metadata in define.xml, datasets in .xpt format) required for regulatory submissions (NDA).
• Completed the timelines for the client depending upon the scope document.
Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/ODS, Excel/Access 2000, UNIX.
EDUCATION:
Masters in Biotechnology from Andhra University, Visakhapatnam, India
Bachelors in Biotechnology, Biochemistry and chemistry from Andhra University, Visakhapatnam, India
TRAINING:
Bio-Informatics Skills: Drug designing software Discovery Studio 2.5 (Accelrys).
Instruments and Techniques handled:
Molecular Biology & Protein Techniques: Plasmid DNA Isolation, Genomic DNA, m-RNA Isolation, Protein Isolation.
Cell Culture: Handled different explant cultures in Plant tissue culture.
Chromatography: Gel Filtration, Thin Layer Chromatography, Paper Chromatography and Column Chromatography.
Immunological Techniques: ELISA, Immuno-diffusion, Electrophoresis technique, handled various therapeutic kits.
Instruments Handled: UV Spectrophotometers, Colorimeters, Incubators, Centrifuges, Ultra centrifuges, Electronic balance, Autoclave and Colony counters.
Credentials:
Secured 2nd place in District level Elocution competition Organized by ICFAI College, Eluru, India.
Secured 2nd place in paper presentation on "Emerging trends in Nutrition and Food microbiology", organized by Dr. V. S. Krishna Govt. College, Andhra University, India.
Participated and served as an organizing committee member for the International Symposium on “Current Approaches in Bio Resource management” Organized by PG Department of Biotechnology, Dr. V. S. Krishna Govt. College, Andhra University, India.
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