Medical Device Sas Programmer

SHILPA GANNARAPU

Sr. SAS Programmer

Email : ******.*********@*****.***

Cell: 520-***-****

SUMMARY

ü Experienced SAS consultant with around 7 years of SAS programming experience in Pharmaceutical industry and Medical device companies. ü Very good in therapeutic domain knowledge such as Oncology, Neurology, Cardiology, Dermatology, Diabetic studies.

ü Extensiveexperience SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODSSAS/STAT, SAS/ SQL in Windows and UNIX environments.

ü Extensive experience in SAS/REPORT generating procedures like PROC SUMMARY, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC FORMAT, PROC REPORT, PROC TABULATE, Data _NULL_ etc. ü Experience in Creation of SDTM domains DM, LB, AE, CM, VS, DS, SV, SE etc. from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide. ü Creates CDISC SDTM & ADaM domains and associated metadata from legacy datasets in sponsor's data standards.

ü Experience in Oncology. Good exposure to CDISC standards, macro development, generation/validation of analysis datasets and TLFs. Extensively worked on data migration of CDISC standards.

ü Worked on Annotations of CRFs for mapping SDTM. Thoroughly did statistical programming across phase I to phase III clinical trials.

ü Created various safety tables like Summary of Demographics, Serious Adverse Events, summary of Labs and CM etc. in various therapeutics like cardiovascular, Respiratory, CNS etc.

ü Performed various QC/ Validations for datasets and TLG's. ü Good understanding of study related Statistical Analysis Plan (SAP) and produced Tables, Listings and Graphs based on the specifications in SAP. ü Meticulously analyzed and validated data sets and SAS outputs with other programmer's outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ. Created formats for the coded data and used PROC SQL for data validation. ü Perform extensive QC (Quality Check) and analysis in reviewing other team members work as well as render primary support and assistance in data validation and data cleaning in all phases of Clinical studies.

ü Knowledge of completely new drug & device release process from IND (pre- clinical) submission to FDA approval, which includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews, integrated safety and efficacy summary (ISS & ISE) for FDA submission.

ü Facilitate the modification and development of existing SAS programs as well as accountable for the creation of new programs using SAS Macros. ü Cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.

ü Outstanding organizational skills including ability to multi-task prioritize and manage complex issues.

EDUCATION:

ü Bachelor of Scinece, Osmania University, Hyderabad, Telangana, India. PROFESSIONAL EXPERIENCE

Johnson&Johnson, NewBrunswick, NJ. Jan 2022– Present Sr SAS programmer

Responsibilities:

ü Program, analyze and evaluate Phase-II and Phase-III of Clinical Trial data projects in Oncology based for patients with Breast Cancer.

ü Worked as a primary programmer for multiple studies. ü Provide programming support for the preparation of integrated reports, submissions and post- submission activities.

ü Excellent work experience in generating tables, listings, and graphs by following the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs), and departmental guidelines. ü Involved in CRF Annotation to ensure that required data is captured completely. ü Utilizing advanced SAS skills, including Macros and SQL procedures to deliver concise and flexible code.

ü Independently developed analysis dataset programs ü Followed CDISC SDTM and ADaM standards for raw and analysis datasets. ü Worked as secondary programmer to validate SAS programs that produce derived-analysis datasets and data analyses.

ü Participate in SOP development for data reconciliation, programming standards, software validation.

ü Responsible for running Pinnacle21 tool and interpreting the reports ü Worked on dropouts and missing Data by approach of generating Last-Observation-Carried- Forward (LOCF) data.

ü Collaborated with statisticians and support programmers on programming tasks and validation ü Implemented QA and QC validation in accordance with departmental SOPs for deliverables. ü Prepared, documented and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical statistical reports and other similar reports. TECHNICAL SKILLS

SAS Tools SAS /BASE, SAS /Macros, SAS /STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS /Enterprise Guide

SAS Procedures PROC Report, Print, Freq, Means, Summary, Univariate, SQL, Sort, Transpose Contents, Options, Import, Export, Format, etc. Operating Systems Windows (95/98/2000, XP, 7), UNIX Applications MS Office, MS PowerPoint, MS Access, MS outlook, SAS /Add-in Databases: MS SQL Server, Oracle, MS-Access.

ü Contributed to the integrated clinical/statistical report and other similar documents. ü Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting Parexel, Hyderabad, India Jan2020- Dec 2021

SAS Clinical Programmer

Responsibilities:

ü Responsible for providing SAS programming and analysis support for phase II and Phase III of clinical trials in different therapeutic areas

ü Phase I Study of Oncology for the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS). ü Experience in understanding and reviewing SAP, SOP and CRF ü Experience working on time sensitive ad-hoc requests from regulatory agencies şszs and internal team

ü Highly skilled in generating analysis datasets, tables, listings, graphs, and reports based on SAP and mock shells

ü Worked on preparing specifications and programming of mapping Raw Datasets to CDISC SDTM standards

ü Created ADaM specifications and analysis data sets for developing TLF's ü Involved in validation of datasets according of CDISC SDTM standards ü Designing and developing SAS macros, standard programs, applications, and other utilities to expedite SAS programming activities.

ü Interacted with other line of functions, such as Biostatics, Data Management to ensure a high level of client satisfaction through successful execution. ü Involved in creation of Case Report Tabulations (CRT’s) and fixing issues in the datasets (XPT) ü Reviewed define.xml and aCRF for submissions

ü Experience in designing and creating analysis database as per the CDISC Analysis Data Model

(AdaM) standards.

ü Worked on Pinnacle 21 compliance tool (Open CDISC Validator) ü Worked on Creation of SDRGs for various studies and explaining the issues from open CDISC validation report for FDA submissions.

Cytel, Hyderabad, India Jan 2018 - Dec 2019

SAS Programmer

Responsibilities:

ü Worked extensively to generate SAS data sets, statistical reports, listings, safety reports for Phase I to III of Cardio-Vascular Clinical Trial Data. ü Review of SDTM, ADaM datasets and eCRF mapping Documents. ü Analyzed Safety and Efficacy Data from Phase I, II and III clinical trials. ü Involved in developing SDTM domains following SDTM IG standards and specifications. ü Converted existing raw data into CDISC standards and reviewed CRFs to ensure consistency and adequacy in data in order to meet the objectives defined in protocol ü Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time.

ü Used statistical SAS procedures like Proc Means, ProcFreq and Proc Univariate for tabulation counts, correlations, data validations, edit checks and SQL Queries to check data for different conditions like duplicatevalues and missing values. ü Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.

ü Worked in resolution of PC and PP domains by mapping PK data. ü Used SAS ODS to produce HTML, PDF and RTF format files. ü Created SAS customized Reports using Proc Report and Proc Template procedures. ü Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs

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