PROFESSIONAL SUMMARY

• Sr. SAS programmer with over 6 years of experience in SAS programming and experience in analysis, design, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries.
• Knowledge of the drug development process with strong experience of analyzing and reporting in phase I, II, III of clinical trial data.
• Experienced in CDISC SDTM mapping from raw datasets, SDTM I.G and annotated eCRF.
• Involved in creation and validation for SDTM and ADaM data sets, tables and listings.
• Developed general-purpose and ad-hoc SAS programs/macros for the extraction, manipulation, analysis, presentation and validation.
• Extensive experience in using various SAS tools like SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACCESS, SAS/CONNECT, and SAS/SQL.
• Provided programming expertise in generating Tables, Listing and Figures TLF's as per the mock shells and SAP for ISS and ISE.
• Knowledge of CRT Dataset Creation, CDISC for regulatory submissions.
• Experienced in OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml.
• Knowledge of FDA regulations, ICH Guidelines and GCP requirements.
• Very good experience in analyzing Case Report Forms CRF data, Clinical Trials, Clinical Data Analysis, Clinical Data migration, Validations and Documentation.
• Highly adaptive to a fast paced team environment and with a proven ability to work in a team environment and individually. Have excellent communication and written skills.

TECHNICAL SKILLS:

PROFESSIONAL EXPERIENCE:

Confidential

Role: Sr. SAS Programmer

Responsibilities:

• Worked extensively on CDISC SDTM domains and generated the xpt files.
• Created ADaM datasets using CDISC standards.
• Well-versed in using OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml.
• Reviewed Protocol, DST Data Specifications Table , DVM Data Validation Manual , Edit Check document, Quality Plan for TLFs, SAP, SOPs, and eCRF layout and eCRF completion Guidelines.
• Annotated eCRF according to SDTM standards.
• Developed DDT's Data Definition Tables for SDTM datasets.
• Worked with Data cleaning and data validation on the work developed by other programmers.
• Developed SAS programs for Edit Checks, also validated listings, summary tables for drug study.
• Performed quality control checks on program code and outputs produced by other team members.
• Created macros to ensure the variables are as per CDISC guidelines.
• Extensively involved in creation and validation of Tables, Listings and Graphs TLG and Ad-hoc reports.
• Extensively used PROC SQL, PROC TRANSPOSE, PROC MEANS, PROC UNIVARIATE, PROC FREQ, PROC PRINT, and PROC COMPARE for checking the assumptions and statistical analysis.
• Generated programs in MACROS to generate graphs, listings, quality tables for clinical study reports and regulatory submissions.
• Customized existing SAS programs and created new programs using SAS MACRO facility to improve simplicity and pace of modification as well as reliable solutions.
• Developed programs for safety and efficacy tables such as Adverse events, Labs, Dose Exposure tables, vitals, ECG, Demographics, Disposition and baseline characteristic tables.
• Handled Dropouts and Missing Data by using Last Observation Carried Forward LOCF .
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML.
• Created formats for the coded data and used PROC SQL for data validations.
• Worked with ARRAYS, first. Variable and Last. Variable.

Confidential

Role: Sr. SAS Programmer

Client:Novartis

Responsibilities:

• Involved in creation and validation of data sets SDTM and ADM .
• Developed specifications for database in CDISC format and involved in programming datasets in CDISC format STDM model 3.1 .
• Involved in running and interpreting WEBSDM checks for derived data sets.
• Involved in running and interpreting OPEN CDISC VALIDATOR for derived sets.
• Importing the data in to SAS from Excel Spreadsheet using PROC IMPORT.
• Program, test, and document databases in accordance with programming standards and validation procedures.
• Validated derived datasets, tables, listings and graphs as per specifications and mockups in SAP
• Generated various Efficacy and Safety Listings, Tables and graphs for several studies
• Used procedures such as Freq, Means, Univariate, GLM, Mixed, T-test, Report, and Transpose to prepare various statistical results in RTF formats
• Involved in creating the data definition table and SAS transport files for submission as a part of the final report to the FDA
• Producing Top line efficacy results and creating analysis dataset for these efficacy results as per the specifications of client
• Created ad-hoc reports using SAS

Confidential

Role: Sr. SAS Programmer

Responsibilities:

• Developed standard agreement documents to facilitate data transfers from External vendors.
• Created SDTM Domains, ADaM datasets, TLF's as primary programmer and validated as secondary programmer.
• Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
• Used Data Null technique for producing customized reports.
• Served on various internal committees to develop macros and standardize processes.
• Extensively used SAS procedures like PROC FREQ, PROC MEANS, PROC REG, PROC CORR, PROC TABULATE and PROC REPORT.
• Generated statistical analysis, tables, listings and graphs for Phase I-II clinical studies.
• Worked with various SAS modules such as SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS/ MACROS to generate statistical deliverables.
• Developed ad-hoc reports as per the Biostatistician and client requests.
• Documented programs while being compliant with ICH-GCP guidelines and SOPs.
• Performed data checks as needed, to ensure integrity and correctness of data displays.
• Created project specific macros and formats to ensure consistency and integrity of data.