Technical Support Project Management
Resume:
Aparna C.L.
Email:******.********@*****.***
SUMMARY
Certified Base SAS 9 programmer over 15 years of experience as SAS Analyst/Programmer with extensive experience in SAS programming.
Extensively worked on clinical trials projects (Phase I - IV) with Biostatisticians, Data Managers and Statistical programmers to create and analyze the clinical data, Tables, Figures, and Listing (TFL), generate Adhoc reports and Integrated Summaries of Efficacy (ISE) and Safety (ISS).
Project Management & providing technical support to the team.
Created, Validated and executed Datasets (SDTM and ADaM), Tables, Listings, Graphs (TLGs) and analysis data set programs of both Safety and Efficacy.
Extensive experience in CRF annotation, SDTM dataset specification as per CDISC standards (SDTM IG v3.1.2, 3.1.3, 3.2) /client requirement.
Strong experience in reviewing issue summary logs from Pinnacle 21 CDSIC validation.
Experience in processing external vendor data such as local labs, IVRS data, PK/PD.
Performed Reconciliation of Data & Edit check programming to identify potential data issues and conducted data validations.
Extensive experience in creating Define.xml & Define.pdf for both SDTM and ADaM by using Pinnacle 21 Community.
Experience in writing/customizing macros to develop concise and reusable code.
Highly self-motivated and goal-oriented professional with rational problem solving and sound decision-making capabilities.
Very good team player with excellent communication skills. Ability to work independently with the least supervision.
TECHNICAL SKILLS
Tools: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, MS Excel, MS PowerPoint, Transdata, Pinnacle 21 Community, Star, Space, Workflow, Phoenix, Venus’s environments.
Operating Systems: Unix, Windows 11/10/98/2000/ME/NT/XP/Win-Vista/Win-7.
Languages: SQL, SAS, R Programming, C, C++
NON-SAS TECHNICAL SKILLS
Design Methodologies:
OOP, OOA/OOD, Unified Modeling Language (UML).
Programming Languages:
VB.NET, ADO.NET, C#, Visual Basic 6.0, VBA, Embedded Visual Basic 3.0, JAVA and T-SQL
Web Development and Scripting:
ASP.NET, ASP, XML, XSLT, HTML, CSS, PHP, WPF, WCF, MVC, Java script and VB Script.
Web Server
.Net Remoting, MSMQ, Web Services, IIS 6.0
Integration Servers:
Microsoft Biz Talk server and MSMQ
Databases:
MS SQL Server 2000/2005/2008, Oracle 9i and My SQL 5.5.
Reporting Tools:
Crystal Report 9.0, Sql Reports
Development Environments and Tools:
Microsoft Visual Studio. NET, Microsoft Visual Interdev, DREAMWEAVER MX 8.0, Microsoft Front-Page, MS-Office,Toad, Microsoft Visual Source Safe, Tortoise, FTP,HP Service desk, lotusnotes.
Operating Systems:
Windows 95/98, Windows NT workstation, Windows 2003 Advanced server and Windows XP.
Design Tools:
MS Visio and ER-Win
SAS PROFESSIONAL EXPERIENCE
Ephicacy, Home Based
Senior Statistical Programmer Sep 2023 – June 2024
Responsibilities:
Worked as an individual contributor in Oncology Study. Supported ADaM Dataset Programming, TLF development, to conduct a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) analysis of a new drug using various datasets to evaluate the drug’s efficacy and safety profiles.
Debug and write SAS macro.
Created Define.Xml and ADaM electronic data package (ADRG).
Ensure data consistency and resolve any discrepancies.
Cytel, Home Based
Senior Statistical Programmer Nov 2021 – Aug 2023
Responsibilities:
Worked in Cytel FSP’s, supporting their Statistical programming team on studies based on Oncology, Multiple Sclerosis and Lupus therapeutic areas. primarily concentrating on CDISC ADAM side of programming involving Open-label studies in Phase 1/1b and Phase 3 to Evaluate the Safety and Pharmacokinetics of and Clinical Activity of drug (or drugs in combination) an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Non-Small Cell Lung Cancer.
Worked on the development of Leaky Pipe app single handedly, which was an automation process to check the generated SDTM and ADAM dataset's compatibility with the specs created within the study.
Providing Support for different studies in FSP’s- i.e., DMC’s, CSR's, interim analysis, adhocs, SLE supporting on SDTM, ADAM, TLF's production and validation and on spec creation and updating whenever required. Got familiarized with FSP's working infrastructure, tools, processes, and systems within 6 months of Orientation, viz. Workflow, Phoenix, Venus’s environments, Space and Star systems.
Focused on providing FSP’s with high quality project work per their SOP’s and Guidance to meet key milestone’s and deliverable dates with accountability factor going strong with being responsible for consistently producing expected results and quality deliverables as per their standards.
Parexel, Home Based
Senior Statistical Programmer Aug 2020 – Oct 2021
Responsibilities:
Worked as a lead programmer with a multi-functional team from USA, China and India.
Served as a core team member with tasks ranging from communication with data management team, biostatistics team and client for all the programming needs.
Generated SAS dataset SDTM and ADAM specifications.
Generated summary tables and data listings, produce graphs, and process lab data, as specified in statistical analysis plan.
Followed SOPS of client and Parexel for all daily operations.
Inventv Health Clinical\Syneos Health, Home Based
Senior Statistical Programmer May 2016 – Aug2020
Responsibilities:
Worked as an individual lead and Co-lead on multiple studies.
Served as the core project team member to design and specify the overall approach to a project’s programming tasks
Supported statisticians with computer programming tasks
Generated summary tables and data listings, produce graphs, and process lab data, as specified in statistical analysis plan
Generated derived SAS datasets for all parameters and ensure consistency among tables/listings
Generated clinical study report tables as well as ISS/ISE tables for FDA submission
Create, test and maintain SAS programs for clinical studies according to departmental standard procedures
Created client deliverables for weekly, SRT, BDR.
Accenture, PA
Clinical SAS Programmer Sept 2015 – April 2016
Responsibilities
Worked with clinical data analysts in reviewing Case Report Form (CRF) to generate data summary and analysis reports.
Involved and worked in coordination with Statisticians to develop the mapping specifications for the development of SDTM datasets.
Extensive interaction with the statisticians to understand the requirements on statistical methods and models.
Developed SAS programs for statistical analyses and data displays.
Generated statistical analysis tables, listings, and figures to analyze the clinical trial data.
Created and validated analysis datasets, tables and listings and figures to support regulatory documents.
Worked with quality team to validate the applications compliance with 21 CFR part 11 regulations.
Worked with various Versions MedDRA getting the adverse event codes and in grading laboratory toxicity grading, WHO drug coding concomitant medications and medical history terms
TAKE Solutions- Navitas, NJ
Clinical SAS Programmer January 2015 – June 2015
Responsibilities
Actively involved in the analysis of clinical trials data along with generation of domains as per SDTM standards.
Review CRFs, protocols, raw data, Data base specifications, EDC data, EDC specifications, Clinical study reports (CSR), Data management plan (DMP), SAP, Diary data, central lab and local lab data
Involved in the design and development of database structure (mapping tables in order to map clinical database to conform CDISC standards).
Involved in design and development of SAS Macros which are generalized, domain specific and study specific to run against the mapping tables for SDTM domains.
Developed verification and validation scripts to check the accuracy of the SDTM domains generated.
Pfizer, PA
Clinical SAS Programmer September 2012 – December 2014
Responsibilities
Validated datasets as required by the client to find the missing data and imported to SAS Environment.
Extracted data from flat files, MS Excel and Oracle Clinical database and created SAS data sets using different SAS procedures and SAS/SQL “Pass through facility”.
Generated Descriptive reports and analysis, basic listings, summary statistic tables, one-way frequency tables, correlations tables.
Performed data cleaning by analyzing and eliminating duplicate and inaccurate data using PROC FREQ, PROC COMP, PROC UNIVARIATE, and macros in SAS.
Developed validated and documented programs to create TLG’s (Tables, Listings and Graphs) as per Statistical Analysis Plan (SAP) using SAS reporting procedures like PROC REPORT.
Developed and used SAS Macros programs to generate tables and listings for clinical and bio-statistical review.
Used PROC COMPARE to conduct quality control checks on files, tables and listing.
Created transport files for FDA submissions.
Onyx Pharmaceuticals, CA
Clinical SAS Programmer April 2009 – August 2012
Responsibilities:
Provided SAS programming and analysis support for Phase II-III clinical trials.
Generated safety tables (Adverse Events, Patient profile, Demographic listing, Vital Signs, Reason for withdrawal by treatment).
Generated high quality reports in the form of listing and RTF using SAS ODS.
Assigned primary programmer to produce tables, listings and figures for the clinical study report (CSR).
Designated secondary programmer to validate SAS programs that produce derived-analysis datasets and data analyses.
Worked with CDISC (SDTM, ADaM) and created annotated Case Report Forms (CRFs).
Worked closely with study statisticians to implement the analysis specified in Statistical Analysis Plan (SAP).
Prepared integrated databases for ISS/ISE.
Worked on pre-existing macros for data validation by checking data distribution and comparison to standard data.
Used SAS/ACCESS to read datasets from Oracle database and also read and write into other PC File formats.
Submitted programs to produce tabulations, graphics, and listings from clinical trial data.
Performed data manipulation using techniques like Merging, Appending, Concatenating and Sorting.
Generated highly customized reports using SAS macro facility.
Environment: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/ACCESS, SAS/SQL, UNIX, Windows.
MMS Holdings, MI
Programmer/Analyst August 2008 - February 2009
Responsibilities:
Data manipulating by MERGE, APPEND, CONCAT, SORT and generated the reports.
Data validation by checking data distribution and by comparison to a standard data.
Used SAS /Base to perform sorting, merging and updating and generated reports.
Created HTML listings, tables and reports using SAS/ODS.
Wrote and modified SAS code in windows environment.
Developed SAS reports using DATA_NULL steps and wrote to External Files.
Run weekly and monthly reports using SAS.
Extensively used statistical procedures like UNIVARIATE, SUMMARY, MEANS, GPLOTS and GCHARTS.
Generate, compare and update the reports, verified for validation.
EDUCATION
Bachelor of Science (Mathematics,Physics,Chemistry), Osmania University.
Hyderabad, India.
Master’s of Computer Applications, Osmania University.
Hyderabad, India.
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