Ankitha Reddy Chintalapudi
Henrico,Virginia
Summary
- Seeking to advance my career as a SAS programmer within a reputable organization where I can leverage my extensive experience in SAS programming to contribute to the organization's growth.
- As a certified SAS Base Programmer with over 6 years of experience in Healthcare, Clinical, and Pharmaceutical industries, I have been involved in Phase II, III, and IV Clinical Trials, ensuring compliance with Clinical Protocol, SAP, internal SOPs, and annotated CRF. My expertise extends to understanding Clinical Trial Phases, clinical protocols/CRF’s/Annotated CRF’s ICH and GCP guidelines, NDA, IND, MedDRA, and 21 CFR PART 11, along with familiarity with Electronic submission guidelines to FDA.
- Collaborating closely with statisticians, Data managers, and Clinicians, I have developed various reports and handled Clinical Data reporting and Data analysis using a range of SAS tools including SAS/Base, SAS/Macros, SAS/Stat, SAS/SQL, SAS/graph, SAS/Connect, SAS/ACCESS, and SAS ODS.
- My experience encompasses Clinical Trials Data captures, Data Validation, Data Management, Statistical Analysis, and Reporting, with a thorough understanding of CDISC (Clinical Data Interchange Standards Consortium) and SDTM process. I have prepared SDTM and ADaM data sets as per CDISC standards and possess knowledge of integrated safety and efficacy summary (ISS & IES) for FDA submissions.
- Additionally, I have demonstrated proficiency in creating SAS data sets, generating listings, Analysis Data Sets (ADS), graphs, and tables (TLG) as per Statistical Analysis Plan (SAP), along with analyzing Case Report Forms (CRF) data, Study Protocol, Statistical Analysis Plan (SAP), and Clinical Data Analysis. My expertise also extends to data cleaning processes and extracting data from various sources like Oracle database, Excel, and flat files using Import techniques.
- I possess strong skills in various SAS procedures such as Contents, Print, Freq, Means, Univariate, Summary, Report, Tabulate, GPlot, Gchart, Format, Transpose, and Proc SQL. Moreover, I have developed routine codes with SAS Macro, debugged macros using options such as MPRINT, MLOGIC, and SYMBOLGEN, and have experience in modifying existing macros.
- Furthermore, I have expertise in converting SAS Datasets to various file types including MS Excel, PDF, and extracting data from various flat files and databases. I excel in analytical thinking, problem-solving, and organization, and thrive in collaborative environments, demonstrating excellent communication skills, self-motivation, teamwork, enthusiasm, innovation, and a penchant for challenges.
Overview
8
8
years of professional experience
Work History
SAS Data Analyst
MedSpace Inc
Dallas, TX
05.2023 - Current
- Responsible for collection, evaluation, initial assessment, and timely submission of adverse experience reports related to the companies marketed and investigational drug products.
- Developed analysis datasets based on the guidelines provided in the SAP (Statistical Analysis Plan).
- Generated reports on AE (Adverse Events) and SAE (Serious Adverse Events) Demographics, Laboratory shift tables by referring to the Statistical Analysis Plan and the Mockup Shells.
- Validated TLGs by writing competing code and comparing the values produced with the source report values.
- Extracted data from the database by SQL PASS THROUGH FACILITY and LIBNAME facility.
- Created reports in PDF, Excel and HTML formats using ODS statements.
- Developed macro programs defining the macro parameters using different debugging options like MPRINT, MLOGIC, and SYMBOLGEN.
- Created Summary tables using procedures like PROC TRANSPOSE, SORT, FREQ, MEANS, SUMMARY, UNIVARIATE, AND TABULATE.
- Created electronic datasets (i.e., SAS Transport Files) for submission by using PROC EXPORT for FDA submission.
- Created SDTM datasets and ADaM datasets according to CDISC standards.
- Participate in the development of clinical programming SOPs.
- Closely work with the statisticians and data managers to identify common factors across the projects.
- Knowledge of FDA/ICH guidelines and industry standard practices regarding clinical programming.
- Contributing to the development and documentation of analysis/clinical data set specifications, safety and efficacy analysis programs and ad-hoc program per requests.
- Created List reports for reviewing AE and SAE reconciliation needs as per Ad-hoc requests provided.
- Performed quality control and validation procedures of tables, listings, and graphs, compared SAS datasets created by others.
- Created Cleansing Reports and prepared Listing reports per serious and non-serious adverse events of company post-marketed drug data.
Clinical SAS Programmer
AstraZeneca
Ontario, Canada
08.2021 - 02.2023
- Involved in managing randomized phase II and III clinical trials data
- Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports
- Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets by using Set and Merge for generating Reports and Graphs
- Developed new or modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs
- Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements
- Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS
- Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation
- Tested and debugged existing macros
- Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission; Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS
- Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GHART
- Wrote programs in SAS to generate reports, creating PDF, HTML listings, tables and reports using SAS/ ODS for Ad-Hoc report generation
- Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate
- Reviewed and provided feedback for Data Integrity Plans.
Clinical SAS Programmer
Everest clinical research
Ontario, Canada
06.2017 - 07.2021
- The projects were on phase II and III studies of anti-cancer drugs
- As a SAS programmer I was responsible for managing and analyzing the clinical trial data in addition to providing reports as per company SOP's and Statistical Analysis Plan (SAP)
- Generated statistical analysis files, summary tables, listings and graphs using SAS/BASE, SAS/MACROS, SAS/MERGE, SAS/GRAPH and SAS/STAT
- Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis
- Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions
- Developed and customized reports using PROC REPORT, PROC SORT, PROC FREQ and PROC MEANS and DATA_NULL_
- Created new datasets from existing data-sets by using concatenation, merging, interleaving and using conditional statements
- Defining, Manipulation, Controlling and Reporting/Storage (Query Language) of Clinical Data by using PROC SQL
- Generated routine and ad-hoc reports using PROC PRINT, PROC SORT, PROC FREQ and PROC REPORT
- Generated required reports using PROC REPORT and PROC TABULATE
- Developed and improved the efficiency of programs through the use of SAS macros
- Created an annotated CRF document that maps CRF data sets to SAS data sets
- Used SAS/ODS facility to generate custom reports and thus directing SAS output to XML and PDF files
- Reviewed the existing SAS code to eliminate any possible errors and improved functionality.
SAS Programmer I
DR.Reddy Labs
Hyderabad, India
08.2016 - 05.2017
- Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis
- Analyzed Phase II and III Clinical Trials
- Experience with SAS programming and in data step and with various SAS procedures in Base SAS and SAS/Stat
- Performed Data analysis, generated reports,listings and figures using SAS TOOLS – SAS/BASE, SAS/MACROS, SAS/SQL, SAS/CONNECT, SAS/ACCESS
- Retrieved ORACLE tables from Oracle Clinical with PROC SQL using PASSTHRU facility
- Used sorting and merging techniques along with SAS functions on the input data sets for Data manipulation, to get the required output and then writing the code using SAS tools
- Created SAS customized reports using the DATA_NULL_ technique for evaluations
- Developed routine SAS MACROS to create tables, graphs and listings
- Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY
- Also produced descriptive statistics using PROC MEANS, FREQUENCY AND UNIVARIATE
- Generated HTML and RTF reports using SAS Output Delivery System
- Used the SAS Macro facility to produce weekly and monthly reports.
Education
Bachelors in Pharmacy -
JNTU UNIVERSITY
Post Graduation -
Healthcare Administration
Skills
- Macro
- Data Analysis
- SAS Macros
- Statistical Analysis
- SAS/SQL
- SAS Procedures
- Unix
- SAS Programs
- Base SAS
- CDISC
- SDTM
- HTML
- SAS Data
- Adam
- Proc SQL
- Ms-Excel
- SAS/GRAPH
- Windows XP
- Ad-Hoc Reports
- FDA
- Clinical Trial Data
- SAS/STAT
- SAS/MACROS
- SAS/CONNECT
- SAS/ACCESS
- SAS/ODS
Timeline
SAS Data Analyst
MedSpace Inc
05.2023 - Current
Clinical SAS Programmer
AstraZeneca
08.2021 - 02.2023
Clinical SAS Programmer
Everest clinical research
06.2017 - 07.2021
SAS Programmer I
DR.Reddy Labs
08.2016 - 05.2017
Bachelors in Pharmacy -
JNTU UNIVERSITY
Post Graduation -
Healthcare Administration
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