Data Quality Assurance
Resume:
Nagarjuna Pavuluri
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PROFESSIONAL SUMMARY
• SAS Programmer with 6+ years of experience in analysis, design, development, testing and validation of projects regarding pre-clinical and all phases (I-IV) of clinical trials in Pharmaceutical and Biotechnology Industries.
• Experience on clinical trial data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data, Concomitant or prior medication data, time-to-event data, physical and vital signs, and the annotated Case Report Forms (CRF).
• Expertise in analyzing and coordinating clinical trial data, generating reports, listings and graphs.
• Guiding, documenting and reporting computer validation inspections in compliance with 21 CFR Part 11, data transmission and integrity check for the existing and in-house Clinical Trial Systems.
• Proficient in debugging, storing and managing SAS data files, merging SAS data sets, SAS Formats, and SAS Informats.
• Thorough hands-on experience in using SAS/ODS to generate different files including XML, RTF, MS Excel, PDF and HTML.
• Experience in Base SAS, SAS/Macros, SAS/SQL, SAS/STAT, SAS/Access, SAS/GRAPH and SAS/ODS.
• Used SAS extensively to analyze clinical data from CRF’s, creating SAS data sets for the purpose of analysis and report writing for clinical trials (Pre-clinical through Phases IV), generating efficacy and safety reports, creating datasets and generating reports using PROC Tabulate, PROC Report, Data Null, SAS arrays, PROC SQL and Macros, and verified and documented programs.
• Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Good Experience in understanding the PROTOCOLS, CDISC Process (SDTM, ODM and ADM Models) and SAP’S.
• Expert in using PROC SQL, PROC REPORT, PROC ACCESS, PROC GPLOT, PROC GCHART, PROC FORMAT, PROC TABULATE, DATA MERGE, SORT to generate
• Flexible, multi-tasking and comfortable working in a consistently busy environment.
• Excellent communication and interpersonal skills.
• Good analytical, problem solving skills along with high leadership quality and able to work independently and in a team environment setting.
TECHNICAL SKILLS
SAS Tools : SAS, Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH,
SAS/ODS, SAS/ACCESS, SAS/BASE
Databases : Oracle, MS SQL SERVER & MS ACCESS
Operating Systems : Windows 2003 Server, Windows NT/2000/XP, UNIX
EDUCATION
Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices
Bachelor of Science in Pharmacy
PROFESSIONAL EXPERIENCE
McKesson, Richmond, VA Nov’ 2009 – Till Date
SAS Consultant
McKesson is one of the leading pharmaceutical and medical supply company, dedicated to delivering the vital medicines, medical supplies and information technologies that enable the healthcare industry to provide patients better, safer care. Service offerings include project management, clinical monitoring, data management, biostatistics, medical writing, quality assurance, and innovative resourcing/staffing solutions. I was involved in analysis of clinical data to evaluate and confirm the safe dosing range, safety and efficacy of Rheumatoid Arthritis molecule.
Responsibilities:
• Created SAS datasets from Microsoft Excel files using Proc Import and Import Wizard.
• Transformed the clinical trial data, subject records entered in the database files to SAS data sets using SAS/Access.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate PROC UNIVARIATE, Data _null_, Proc Plot, and Proc Gplot SUMMARY and also provided descriptive statistics using PROC Means
• Retrieved tables from Oracle Clinical databases with PROC SQL using ‘Pass through Facility’.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to Produce ADHOC reports for presentation and further analysis.
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Performed quality controls on SAS programs and also documented all project data flows and programs.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.
Pfizer Pharmaceutical, Groton, CT Jun’ 2008 – Nov’ 2009
SAS Consultant
Pfizer is one of the largest pharmaceutical companies with largest field force, dedicated to discovering and developing the new, and better, ways to prevent and treat disease and improve well-being of the people. Pfizer has a particular focus on
Responsibilities:
• Developed and implemented clinical trial reporting systems in support of electronic regulatory submissions.
• Provided programming support for Clinical Trial/ SAS interface.
• Participated in a pilot project involved in the development of CDISC’s SDTM standard datasets.
• Delivered statistical programming expertise in Phase III study to conduct statistical analysis in order to confirm the safe dosing frequency, safety and efficacy.
• Developed Efficacy, Safety Tables and listings for phase III studies and presented same data in SAS Graph using ANNOTATE for presentations and quick look at interim analyses.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation and further analysis.
• Provided programming support for Clinical Trial/ SAS interface.
• Performed Data Analysis on the data sets using Proc Anova, Proc Means, Proc Univariate, Proc Reg, and Proc Freq.
• Wrote independent SAS programs to create, validate TLG, analysis datasets, and SAS standard macros for Phase II, III studies
• Generated highly customized reports using SAS macro facility, Proc Report, Proc Tabulate, and Proc SQL.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.
Barr Pharmaceuticals, NJ DEC’ 2006 – MAY’ 2008 SAS Consultant
Barr Pharmaceuticals is a biopharmaceutical company engaged in the discovery and commercialization of new therapeutics that treat serious and life-threatening diseases. Barr has a particular focus on developing new therapeutics for the infectious disease market to combat the problem of antibiotic resistance. Barr has established two product development programs that are expected to yield multiple products for the treatment of infectious diseases and for other therapeutic indications. I was involved in Phase II, Phase III studies that assess the clinical efficacy of Study medicine.
Responsibilities:
• Received different SAS transport files from Data managers. Used SAS program to convert SAS transport file to current platform.
• Developing and maintaining existing SAS programs that were used for creating various reports, lists, etc. for regulatory submissions.
• Generate the required SAS datasets from large database using Sorting and Merging techniques.
• Existing SAS Macros were used to generate text files on a weekly schedule.
• Used FILENAME fileref in a SAS procedure to output analysis (Number of records, Patients, Visits, etc.) of text file to another file.
• Proc SQL, Proc Import was used to retrieve data from databases like Oracle, and Excel.
• Displayed reports, lists in Intranet website. These online reports were used by other groups. Reports and lists were updated weekly or monthly base on schedule using SAS - output delivery system ODS.
• Generated Customized Reports using the Data _Null_ technique for regulatory submissions.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.
Parexel, India JAN’ 2006 – DEC’ 2006
SAS Programmer
Responsibilities:
• Extensive use of PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC MIXED, PROC REPORT, PROC TABULATE, Data _Null_, and Chart procedures Ascertaining quality and standards for the code changes made.
• 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.
• Participated in maintenance of software applications and requirement reviews.
• Collected raw data and created data sets for all programmers, and also assisted in identifying enhancements and new features.
• Implemented 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.
• Performed Data entry and conversions, data validation and corrections, uploading/ downloading data from/to a PC.
• Used SAS for pre-processing data, data analysis, generating reports, statistical analysis, and graphs.
• Responsible for locating appropriate databases for projects, implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.
• Tested and debugged against the test data.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.
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