OBJECTIVE

• To obtain a challenging position of Statistical Programmer in an inimitable Clinical Research, Pharmaceutical, Biotechnology, Health Care Company where I can effectively contribute my skills, intelligence and sophistication which will be progressive and beneficial to the organization.

SUMMARY

• Certified SAS Clinical Trials Programmer with over eight years of experience in support of Clinical Trial projects in Clinical industry.
• Excellent knowledge in SAS programming application: BASE SAS, SAS\STAT, SAS\GRAPH, SAS\MACRO, SAS/ODS and SAS\SQL in both windows and UNIX environment.
• Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs.
• Thorough experience of CDISC and SDTM process. Prepared SDTM and ADaM data sets as per CDISC standards.
• Created SAS data sets and generated reports, tables, listings and figures (TFL’s) as per Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP), also performed validation of the datasets.
• Extensive experience with generating and validating Tables, Listings, and Figures.
• Proficiency in writing maintainable, supportable, and well - documented code.
• Good at using various SAS report generating procedures like PROC PRINT, PROC REPORT, PROC SUMMARY, PROC TABULATE, PROC IMPORT PROC MEANS PROC TRANSPOSE, PROC UNIVARIATE, PROC FREQ.
• Performed conversion of SAS Datasets to various file types including MS Excel, PDF, RTF and extraction of data from various flat files and database.
• Created various SAS Reports satisfying the 21CFR-11 (Code for Federal Regulations), familiar with FDA submissions.
• Used SAS ODS to produce HTML, PDF and RTF files

TECHNICAL SKILLS

Operating Systems: MS Windows, Unix.

Statistical Software/Database: SAS/BASE, SAS\MACRO, SAS\STAT, SAS\SQL, SAS\ACESS,SAS\GRAPH, SAS|ODS, CDISC - SDTM and ADaM.MS Access, Trial Master Database.

Office Tools: MS Word, MS Excel, MS Project, MS PowerPoint

PROFESSIONAL EXPERIENCE

Confidential, Nashville, TN

Senior Statistical Programmer

Responsibilities:

• Create, review and/or approve annotated CRF to SDTM datasets.
• Responsible for the translation of the SAP into Programming specifications for analysis data model (ADaM) datasets.
• Review and provide input on key study-related documents produced by other functions such as case report forms, data management plans, statistical analysis plans the TFL specifications.
• Responsible for the development, review, validation and execution of SAS programs to generate presentation-ready outputs (e.g. Tables, Figures and Listings) as defined in the statistical analysis plan.
• Extensively worked on Oncology Trials and Oncology endpoints like Progression-Free Survival (PFS), Time to Event (TTE), Duration of Response (DOR), Overall survival (OS).
• Used statistical procedures like PROC LIFETEST to determine the survival estimates and confidence Intervals.
• Write and validate study and product-level macros and utilities.
• Review of statistical output and clinical study reports.
• Program and integration of databases from multiple studies or sources.
• Ensure the accuracy, quality and timelines of all work completed for the project.
• Communicate effectively within a multi-disciplinary project team and external resources to complete assigned tasks on time and within budget.
• Responsible for accuracy and reliability of results.
• Function as study lead programmer on one or more clinical trials.
• Manage project budget and resource requirements.
• Carry out all activities as per SCRI SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).

Employer Name:Arkstek Inc. Aurora, CO Dates:

Confidential, Nashville, TN.

Clinical SAS Programmer

Responsibilities:

• Understanding and using departmental utilities, processes, and procedures where applicable.
• Involved in publications programming and testing of utility macros for standard reports and validation.
• Involved in analysis of Phase I and II Oncology clinical trials.
• Extensively worked on Oncology Trials and Oncology endpoints like Progression-Free Survival (PFS), Time to Progression, Time to Event (TTE), Duration of Response (DOR), Overall survival (OS).
• Create SDTM datasets as per CDISC standards.
• Used OpenCDISC Validator to check the SDTM data compliance with CDISC standards.
• Developed and Validated SAS programs and macro codes to produce analysis datasets and reports.
• Generated analysis datasets in ADaM standards and performed statistical analysis on data as per the requirements in the SAP and Protocol
• Generated tables, listings and graphs with the help of SAS/BASE, SAS/STAT SAS/SQL, and SAS/GRAPH in Windows environment.
• Developed programs for pooling of SDTM data for ISS (Integrated Summary of Safety) analysis.
• Produced Safety and Efficacy reports in RTF format.
• Worked with Data management team, investigating data issues and solving problems.
• Accuracy, completeness, quality, and timeliness of clinical programming deliverables.
• Performed QC of derived datasets, TLFs and coded programs and involved in Data Validation.
• Performed program documentation on all programs, files and variables for future .
• Program all study-specific edit checks and review listings.

Confidential, TX.

Graduate Assistant

Responsibilities:

• Performed teaching assistant duties
• Performed research under the direction of one of the faculty member in the Biotechnology Graduate Program
• Performed study to determine the efficacy of BCG vaccine against tuberculosis infection through different routes of immunization.
• Performed different immunological assays (ELISA, ELISPOT, RT-PCR, FLOWCYTOMETRY) to determine the frequency and to measure, quantify the cytokine producing cells that are critical for immunity against Mycobacterium tuberculosis (M. tb).
• Performed Statistical analysis of data obtained from immunological assays using SAS and Graphpad prism to generate the results (outputs) in form of Tables and Figures to determine the efficacy of BCG vaccination through different routes of immunization.

Confidential

Clinical Data Analyst I

Responsibilities:

• Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS Datasets CVS and Metabolic.
• Extensive interaction with the functional users to understand the requirements on statistical methods and measures.
• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.
• Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.
• Worked on Phase I and II data. Some of the data used includes prescription data, sales rep activity data, and physician profile information.
• Produced data listings, summary tables and graphs.