Sr. SAS Programmer

Vijaya

Email: adiv3q@r.postjobfree.com

Professional Experience

•8 years of hands on experience in Phase I-IV clinical trials data analysis using SAS in pharmaceutical companies and CROs. Strong understanding and experience on Phase I to Phase IV clinical trials data in various therapeutic areas such as Oncology, Ophthalmology, Respiratory, Metabolic Disorders, Vaccines, Cardiovascular etc. Extensive experience with development and validation of CDISC compliant SDTM and ADaM datasets.

•Experience in generation of Tables, Listings, and Figures (TLF’s) by following Statistical Analysis Plan (SAP), Mockup shells, and Programming plan. Experience in independent and manual validation of TLF’s by thoroughly following study specification documents. Extensive experience with Base SAS, SAS/Macros, SAS/GRAPH, SAS/STAT and SAS/SQL.

•Extensively worked on different PROCs like PROC FREQ, PROC MEANS, PROC SORT, PROC FORMAT, PROC REPORT, PROC SQL, PROC TRANSPOSE, PROC UNIVARIATE, PROC COMPARE, PROC GPLOT, PROC LIFETEST, PROC REG, PROC BOXPLOT and PROC GHART etc. Experience in developing detailed and well-written SDTM and ADaM Data Specifications by following study Protocol, SAP, Mock-up shells, and CDISC standards.

•Generated ad-hoc reports as per requests from the statistician with challenging timelines. Working experience in Integrated Summaries of Safety (ISS) and Efficacy (ISE) involving pooling of data from 30+ different studies, datasets creation and tables programming. Familiar with Good Clinical Practice (GCP) guidelines provided by ICH.

•Proven ability to manage multiple assignments and handle changing priorities in a fast-paced environment. Worked with cross-disciplinary teams, Senior Statisticians, Clinical Data Management, Medical Writers, and Project Managers to assure programming needs are met effectively within challenging timelines.

•Perform Quality Testing/User Acceptance Testing. Generating and validating SDTM. Generating complex ad-hoc reports utilizing raw data. Have ISTQB certification.

TECHNICAL PROFILE

CDM Tools : Oracle Clinical

SAS Tools : SAS v9.4, Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/Graph

Languages : SQL, C

Databases : Oracle, SQL Server, MySQL.

Tools : Oracle Clinical, SAS EG

Operating System : Windows, Linux

PROJECTS AND ROLES

Confidential Oct 2018 – Present

Sr. SAS Programmer

Responsibilities:

•Involved in SAS programming with clinical trials data for Phase I - IV in various therapeutic areas such as Ophthalmology, respiratory, and metabolic disorders.

•Developed ADaM data specifications by thoroughly following study protocol, SAP, Mockup shells, and CDISC ADaM IG.

•Created and validated SDTM and ADaM datasets asper data specifications for various safety and efficacy data.

•Used Open CDISC to validate compliance of CDISC datasets for the submission.

•Wrote independent SAS programs to create and validate Tables, Listings, and Graphs.

•Developed reports for Primary/Secondary/Exploratory endpoints, Adverse Events, Labs, Concomitant Medication, Exposure, Baseline Characteristics, and Disposition etc. using various SAS procedures such as Proc Univariate, Proc SQL, Proc Freq, Proc Means, Proc Summary, Proc Contents, Proc Sort, Proc Report and so on.

•Developed SAS macros for standard reports such as adverse events tables, descriptive & frequency tables for continuous & categorical safety data.

•Extensively used PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC MIXED, PROC REPORT and PROC TABULATE for data analysis/reports.

•Created ad-hoc reports such as datasets and TLGs under challenging timelines.

•Provided data as SAS transport files, other appropriate deliverables and documentation for regulatory submissions.

•Performed data checks on data received from data management (CDM) and reported findings to CDM.

•Actively participated in team meetings for study status and programming

Confindential March 2016 - Sep 2018

Sr. SAS Programmer

Responsibilities:

•Involved in SAS programming tasks associated with Phase II and III clinical trials of Oncology study.

•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.

•Project focused on the development of innovative products for the treatment of cancer and study of epidemiology of chronic illness (Phase II & III).

•Used SAS for pre-processing data, SQL queries, data analysis, statistical analysis and generation of reports.

•Involved in writing SAS code to help in the process of quality control by implementing various statistical procedures like Proc Freq, Proc Means, Proc Univariate and other procedures like Proc Summary, Proc Transpose, Proc SQL and Proc Print.

•Extensive experience with core SAS reporting technologies and procedures, including SAS/Base, SAS ODS, the SAS Macro Language, Proc Report, and Proc Tabulate.

•Extensively used SAS ODS for generating reports in specific output formats like RTF, PDF etc.

•Developed efficient, well-documented, readily comprehensible, and modifiable SAS code using SAS BASE and SAS Macro facility.

•Wrote batch files for automation of the complete study run process.

•Created complex and reusable macros, extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Also, tested and debugged existing macros.

•Involved in developing, debugging, and validating project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.

Confidential Jul 2014 – Feb 2016

SAS Programmer

Responsibilities:

•Developed Listings, Tables and Graphs to access Safety and Efficacy during Phase I-III trials Randomized, Blinded, Well controlled studies and Open label studies.

•Created Analysis Data Sets following ADaM standards from raw OC data sets and also from SDTM domains as source according to specifications by self-creation based on mock shells and SAP.

•Participated in writing of clinical trial reports (phase I-II), analyzing, and presenting trial results for epidemiology of diabetes clinical trial

•Created Demographic data tables, Adverse Events (AE) tables, Serious Adverse Events (SAE) tables, Laboratory data tables etc.

•Developed specifications/ programs for Derived datasets based on the requirements from the SAP.

•Enumerated a list of physical and logical problem areas in datasets across studies for ISS/ISE planning and contributed to the analysis plan.

•Involved in CDISC activities of Legacy and Ongoing studies to follow complete SDTM following SDTM IG 3.1.2 and also ADaM standards following ADaM IG 1.0.

•Developed SAS Macros to create tables, graphs and listings for Clinical Study Reports and regulatory submissions.

•Used SAS Base procedures such as PROC SUMMARY, PROC REPORT and SAS GRAPH for designing statistical summary tables and graphs.

•Designed, created and maintained the database, as well as developed and generated reports, tables and listings using SAS.

•Used Output Delivery System (ODS) facility to write safety and efficacy reports directing SAS output to RTF listings, tables and reports.

•Extensive use of the SAS Macro facility to write routine monthly reports and to create tables, graphs and listings.

•Involved in creating Annotated CRFs and Transport datasets in XPT format for client.

•Performed CDISC SDTM Mapping of variables to make the raw data conform to the SDTM 3.1.2 model.

•Established domain models according to SDTM specs and also created new domains that are CDISC compliant

•Contributed in analysis of PK/PD data by creating ADaMs.

Confidential Jan 2012 – Jun 2014

SAS Programmer

Responsibilities:

•Created analysis data sets and TLF’s.

•Generated safety tables, efficacy tables, patient profile, demographic listing, vital signs and reason for withdrawal from the treatment for FDA submissions.

•Interacted with Statisticians for requirements gathering and report finalization.

•Involved in validating and QC of the efficacy and safety tables.

•Created SAS programs for generating data listings for data review meetings.

•Enhanced reports through the use of labels, SAS formats, User-Defined Formats, Titles and Footnotes.

•Delivered Reports to the regulatory department in the form of password protected or encrypted zip files. Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.

•Created SAS customized Reports using the Data _Null_ technique.

•Used SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analyses

EDUCATIONAL PROFILE

•Bachelor of Science in Bio Sciences from Sri Krishnadevaraya University

•Bachelor of Education from Rayalaseema University

CERTIFICATIONS:

•ISTQB Certification

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