SUMMARY:

• Certified SAS Programmerwith 7 Years of Experience within the pharmaceutical/biotech industry and CRO.
• Proficient in creating CDISC SDTM (V 3.1.1, V 3.1.2) and ADAM (V 1.0) datasets compliant with CDISC standards.
• Experience in preparation of reports, tables, listing and graphs using Base SAS, SAS/GRAPH and SAS/STAT.
• Experience in Data mapping from non - CDISC SDTM to SDTM and creating Adam datasets from SDTM.
• Generated safety and efficacy analysis datasets based on dataset specifications using CDISC SDTM, ADaM standards.
• Experience in generating and validating Tables, Listings and Figures.
• Familiarity with clinical trial design and analysis activities and good knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
• Provided support for coding of adverse and concomitant medications data using MedDRA and WHO Drug dictionaries
• Developed and maintained SOP’s for statistical programming standards and validation for clinical data analysis.
• Assisted ISS & ISE programming for integrated summary report (ISR).
• Provided input in developing specifications of analysis datasets, validation plans, and other related documents.
• Strong SAS programming background for maintaining existing code, ad hoc reporting and supporting the reporting functions. .
• Possess sound working knowledge of CRF Annotation (SDTM Submission) and Edit Checks for Data management team if requested, and so on.
• Good team player with excellent communication, analytical and problem solving skills.
• Extensive experience in Cardiovascular, Immunology and Oncology therapeutic areas.
• Ability to work independently and in a team.
• Programming experience in both Windows and UNIX environments.

TECHNICAL SKILLS:

SAS Tools: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL and SAS/ODS

Languages: C, SQL, Visual Basic 6.0

Databases: Oracle Clinical 4.5.0, Clintrial, Rave, Inform

Operating Systems: Windows and Unix

PROFESSIONAL EXPERIENCE:

Confidential, NJ

Sr. Statistical Programmer

Responsibilities:

• Generated Analysis data sets for the statistical analysis as per the protocol, Statistical Analysis Plan (SAP), mock table shells and other guidelines as provided by Biostatistics
• Created custom Templates to be used with ODS PDF to produce user defined/ custom formatted reports
• Extensively involved in the process of validation for Datasets, Tables, Listings and Figures(TLF’s)
• Developed SAS Ad-hoc programs and Edit-Check Programs for Clinical Data.
• Created custom Templates to be used with ODS PDF to produce user defined/ custom formatted reports
• Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Tested and debugged existing programs/macros as well as extensive Ad-hoc programming

Confidential, East Hanover, NJ

Sr. Statistical Programmer

Responsibilities:

• Work extensively to generateSASanalysis data sets, safety reports for cross-functional teams for Phase I to II of OncologyClinicalTrial Data.
• Produced tables for Tumor evaluations, change from baseline and change from minimum tumor measurements, tumor response based on both investigator response and calculated response, time to event data like time to new lesion, time to progression, time to death, progression free survival.
• Work on CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Extraction of the e-source data from internal sources/importation of the data from external sources. These data are all imported into SAS and structured to meet our internal CDISC SDTM standards
• Experience in Data mapping from non-CDISC SDTM to SDTM and creating ADaM datasets from SDTM.
• Attend project team meetings, worked with Bio-Statisticians, Data Managers, and provided feedback for Data Integrity Plans.
• Create SAS programs to generate Derived/Analysis datasets, Data Listings, Summary Tables, and Graphic displays according to company standards.
• Provided programming support, utilized and modified standard programs to generate reports in compliance with SOPs.
• Generate Ad-hoc reports and customized reports by using generally accepted Programming Standards and Techniques to assure efficient program logic and data manipulation.
• Establish and maintain a sound working relationship and effective communication within Bio-statistics, Statistical Reporting and Data Management. Also coordinate and interact with other departments to ensure clean and accurate data, Quality Assurance standards and Data Validation.
• Generated Kaplan-Meier survival plots using Proc LIFETEST and Proc GPLOT

Confidential, Durham NC

Statistical Programmer

Responsibilities:

• Responsible for the creation of analysis datasets and clinical study report displays
• Involved with the validation of analysis datasets, tables and listings
• Generated tables and listings as per the specifications of display templates
• Generated RTF and PDF reports, using SAS - output delivery system(ODS)
• Updated the standard macros based on the requirements
• Created utility macro to randomly select sites and subjects and provide the list for the clinical for further monitoring of subjects
• Worked on mapping of SDTM as per the client requirements
• Involved in various meetings with the statistician, data management and clinical
• Programmed Ad-hoc reports

SAS Programmer Analyst

Responsibilities:

• Created SAS datasets by extracting data from databases into SAS system for Phase I-III Clinical studies.
• Created Analysis datasets.
• Developed Macros for Report Generation.
• Developed Macros for GVK Library.
• Cleaned of data using data step and Base procedures.
• Merged and summarized data using Proc SQL, Proc Format, and Proc Sort etc.
• Used ODS in order to generate PDF, RTF files.
• Used procedures like PROC FREQ, PROC UNIVARIATE, PROC MEANS,
• PROC SORT, PROC REPORT, PROC TABULATE, PROC SQL and PROC PRINT