SUMMARY

• SAS certified Base SAS programmer wif over 8+years of programming experience in analyzing data from Clinical Trials in development, design, testing and implementation of various projects for Pharmaceutical, Biotech and CRO industries.
• Hands on experience in analyzing and reporting of all phases (Phase me to III) of clinical trials data, creating tables, listing and generating graphs according to SAP.
• Experience in identifying data issues by developing study specific Edit Checks, reviewing annotated CRF.
• Hands on experience in producing SDTM and ADAM domains in accordance wif CDISC standards.
• Good understanding of CDISC SDTM models and experience in converting the legacy data to CDISC SDTM standards.
• Experience in creating Specification and implementing SDTM domains according to eCRF, SAP and SDTM IG.
• Experience in Working on different therapeutic areas like Diabetic and Oncology etc.
• Involved in integration of the data from various studies for Integrated Summaries of Safety (ISS)
• Involved in Ad - hoc programming as per regulatory and biostatistician request.
• Utilizing advanced SAS skills, including Macros and SQL procedures to deliver concise and flexible code.
• Generated HTML, Excel and RTF reports using SAS ODS.
• Involved in validation of datasets, tables, listings and figures of fellow programmers programs by Independent programming and electronic check.
• Hands on experience in using SAS/STAT Procedures such as PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, PROC GLM, PROC LIFETEST etc.
• Good understanding of CRF Annotation, 21CFR part 11 guidelines, FDA regulations, WHO drug and MedDRA dictionaries.
• Hands on experience in using various SAS tools such as SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/CONNECT and SAS/SQL.
• Excellent analytical, problem solving, verbal and written communication and interpersonal skills. Proactive, flexible and well organized.
• Ability to work in a team as well as independently to accomplish team goals.

TECHNICAL SKILLS

Operating System: Windows 98/2000/XP/Vista, Windows 7 & 8, UNIX

SAS Tools: BASE SAS (MACROS, ODS, SQL), SAS/ACCESS, SAS/GRAPH, SAS/STAT, SAS/ASSIST, SAS/CONNECT

Application Software: MS Office - Outlook, Excel, Power Point and Word

Programming Languages: SQL

Statistical Software: SAS 9.3, SAS 9.2, SAS 9.1.3 SAS 9

PROFESSIONAL EXPERIENCE

Confidential, CA

Statistical Programmer

Responsibilities:

• Worked as Statistical programmer for Phase II and III studies. My responsibilities includes implementing statistical analysis according to SAP to meet project and protocol deadlines.
• Programmed SDTM domains and ADAM datasets and generated TLF's.
• Involved in analyzing and generation of reports for Phase II and III of clinical trial data.
• Develop, modify, validate and implement SAS programming according to Statistical Analysis Plan (SAP).
• Performed Data analysis, statistical analysis to generated reports like tables, listings and graphs.
• Involved in Creation and Review of SDTM specifications and Performed CDISC SDTM Mapping of variables to make the Meta data confirm to the CDISC standards in compliance wif SDTM 3.1.2 and annotated CRF accordingly.
• Created ADaM datasets from the SDTM domains and generated safety & efficacy tables, listings, and graphs (TLG).
• Successfully validated datasets, TLG’s through independent validation using Proc Compare and departmental macros.
• Extensively used Macro facility and developed utility macros for the production of Datasets, Tables, Listings and Graphs.
• Performed ad hoc programming as per regulatory requests.
• Collaborated wif managers, statistician, and medical writer back and forth for abstract, Manuscript and posters.
• Interacted wif Clinical, Regulatory and Data Management colleagues to coordinate collection and reporting of clinical trial results.

Confidential, NJ

Statistical Programmer Analyst

Responsibilities:

• Worked as a Statistical Programmer and responsible for developing datasets, reports like tables, listings and figures for various studies of Phase II and III of clinical trial data.
• Involved in multiple projects and interacted wif other SAS programmers, statisticians and data managers to analyze data.
• Involved in complete SDTM mapping of a study from raw data using SDTM IG 3.1.2, aCRF and SAP.
• Involved in developing specs to map a clinical study in compliance wif SDTM IG and annotated CRF.
• Worked on various Safety and Efficacy Analysis datasets using ADaM 1.0 version from SDTM Domains and developed Tables, Listings and Graphs.
• Validating and QC of the datasets, TLF's by both parallel and independent programming.
• Developed routine SAS macros to create Datasets, tables, listings and Figures by using Macro Facility.
• Pooling all the data from different studies to prepare integrated summary of safety (ISS) reports for NDA Submission and MAA filing.
• The reports and listings were generated using Proc Report, Proc Means, Proc Freq, Proc Univariate, Proc Print, and Proc Transpose, Macro statements, Macro functions and Standard Macros.

Confidential

SAS Programmer

Responsibilities:

• Created analysis datasets from the raw datasets as per the dataset specification document, and generated the tables, listing and graphs as per the SAP and mock-up shells.
• Ensured statistical programs comply wif the programming coding standards and utilize available
• Standard reporting systems, as well as macro utility programs.
• Implemented CDISC standards and creating SDTM datasets from raw datasets
• Created ADaM datasets from SDTM datasets as per the ADaM specification document.
• Extensively worked on generating the Tables, Listings and Graphs and also generated ad-hoc reports as per the data managers, medical writers and statistician’s request.
• Generated reports for data analysis and validation on the datasets using various Base SAS procedures as well as SAS/STAT and SAS/GRAPH procedures.
• Performed Quality Control checks (QC) on the work performed by primary programmer.
• Extensively used SAS Macro facility to provide reusable programs that can be conveniently used time to time.
• Ensured SAS program output matches the requirements of the Statistical Analysis Plan mock-up shells.
• Generated output in various formatted files such as RTF and PDF using SAS/ODS.
• Generated Ad-hoc reports as per the data manager, medical writer and statistician request.

Confidential, PA

SAS Programmer

Responsibilities:

• Worked as SAS programmer and responsible for supporting of Phase me & II of clinical trial data analysis and developing the SAS programs by following Statistical Analysis Plan.
• Responsible for developing datasets, tables and listings according to SAP.
• Created Analysis datasets from raw data referring to the specifications provided according to CRF and Statistical Analysis Plan.
• Worked closely wif clinicians, biostatisticians and data managers for analyzing of clinical study data.
• Involved in developing and validation of Analysis datasets from raw data by using eCRF and SAP.
• Produced data listings, summary tables and graphs for analysis.
• Successfully validated study TLG’s and analysis datasets through independent validation using Proc compare.
• Debugged SAS programs using PUT, Data NULL statements in code reviews and testing.
• Generated customized reports by using PROC TABULATE, PROC REPORT, and PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ and PROC UNIVARIATE.
• Prepare summary reports directing SAS output to RTF, HTML & PDF files using output delivery system (ODS) facility.
• Worked wif data manipulation technique- sorting, merging, concatenating and printing data using PROC PRINT, PROC SORT and PROC TRANSPOSE respectively.
• Imported data in the form of SAS datasets from flat files of various formats like pipe delimited, tab delimited, .CSV, .XPT etc.