SUMMARY

• 6 years SAS programming experience in the pharmaceutical industry.
• 对临床试验有良好的了解, 其中包括临床程序代码, 审查和评价), 安全报告, 不良事件报告审查, integrated safety and efficacy summary and risk benefit for FDA submission, 电子提交.
• Very good knowledge about all Phases of Clinical Trials in different Therapeutics areas.
• Hands on experience in the creation of case report tabulation data definition specification (CRT-DDS/define.xml) and experience in providing support in the development of an automation tool for the creation of define.XML和定义. PDF.
• Intensive exposure to SAS Programming-Macro Facility used different SAS Procedures, 制作报告(过程报告), SAS格式和信息, SAS功能等.
• 了解protocol, SAP, sopf和crf.
• 有sas数据集准备经验, 表, 根据规格的清单和图表, 方案和统计分析计划.
• Extensive experience inSAS/BASE, SAS / STAT, SAS/SQL, SAS/MACROS, SAS/ODSandSAS /图.
• Familiar with Code of Federal Regulations (21 CFR Part 11) and e-submission standards for FDA.
• 熟悉CDISC标准(数据模型).
• Created programs to 验证 datasets compliance to CDISC SDTM standards.
• Knowledge of Medical Dictionaries like MedDRA and WHO Drug.
• Hands on experience in creating datasets based on implementation guides (IG) of CDISC SDTM 3.1.1和3.1.2规格与ADaM.
• 使用宏和特设报表.
• Working on Multiple Projects and under Tight Timelines.
• 优秀的沟通能力.

技术技能

SAS技能: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/MACRO, SAS/ODS

数据库: 甲骨文,MS-SOL.

工具: MS Office 95/XP/2003/2007, Sigma Plot, MS Excel, Image-J, Examin-IR (Image analysis).

操作系统: UNIX, MS Windows (95,98,2000, XP).

专业经验

保密,新泽西

情景应用程序的程序员

职责:

• Reviewed protocol, CRF and SAP for creating Metadata sheet and creating SDTM data set.
• 从CRF中创建元数据表.
• 从元数据Excel工作表映射SDTM域.
• 创建的分析数据集, 使用Base/SAS的表列表, SAS / STAT, SAS宏, SAS/SQL和SA/ Report.
• .Produced reports using Proc意味着, Proc频率, Proc SQL and proc reports.
• 使用ODS生成HTML、PDF和RTF格式的报告.

环境: SAS/BASE, SAS/Macro, SAS/SQL, SAS/ODS, SAS/Window and Excel.

保密

情景应用程序的程序员

职责:

• Extensively programmed in SAS/Base, SAS/Macros, SAS/Stat, SAS/Graph, SAS/SQL and SAS/Report.
• 从遗留/原始数据集创建SDTM数据集.
• 开发, 测试, 验证, implement and maintain SAS programs for the automation tool which creates the define.XML和定义. PDF.
• Generate the Datasets and TLF's for the Regulatory Submissions.
• Created Programs to 验证 datasets CDISC SDTM compliance.
• 为客户创建企业社会责任标准TLG.
• 综述了协议, CRF, 以及用于创建分析数据集的SAP, 表, 清单和图表使用base /SAS, SAS / STAT, andSAS /图.
• Generated reports of standard analysis using Proc报告 and data null and successfully handled missing data and dropouts using Last Observation Carry Forward and Worst Observation Carry forward logics.
• Designed and 验证d new and existing programs depending on the requirements.
• Produced reports using Proc意味着, Freq, SQL, Report, and Summary.
• Used Output Delivery System (ODS) to produce HTML, PDF and RTF reports.
• Ensure the proper and timely delivery of ad-hoc reports as required.

环境: SAS/Base, SAS/SQL, SAS/Marco, SAS/ODS, SAS/Graph, SQL/Windows, Excel.

机密，埃克斯顿，宾夕法尼亚州

SDTM开发者/程序员

职责:

• Involved in SAS programming for Clinical trials in Oncology and e-submission to FDA.
• Reviewed protocol and Case Report Forms to identify errors of the clinical trial data.
• 开发ed specifications for SDTM conversion and mapping programs.
• Involved in Mapping and Integrating study data to a CDISC-compliant proprietary analysis data system.
• Validation all the tables and listings using validation rules in programing SOP’s.
• Attended content reviews/workshops for respective Domains/Dataset per assignment
• Participated in weekly meetings with team lead to discuss about work progress and quires regarding project.
• Design and develop standard SAS macro for SDTM domains.

环境: SAS 9.3 version, SAS/base, SAS/macro, SQL, MS Office, Excel, Windows

机密，纽敦，宾夕法尼亚州

情景应用程序开发人员

职责:

• Involved in phase I, Phase II and Phase III clinical trial data.
• 开发ed SAS program to load data from source and created study specific datasets, which are used as source data sets for report generating programs.
• 使用各种程序，如Proc打印, Proc报告, Proc意味着, Proc比较, Proc转置, Proc汇总, Proc频率, Proc总结, Proc排序, Proc SQL, 程序的单变量和程序内容.
• 开发ed SAS宏s to improve the consistency of results.
• Generated tables, Listings and graphs for clinical study reports.
• Generated ad-hoc listings using Proc Print, Proc report, Data null and Proc Sql.
• Worked with Bio-Statisticians, Data Managers and Clinical Research managers as required.

环境: SAS版本9.1、SAS/Macro、SAS/Base、SQL、MS Office、UNIX

保密

职责:

• This includes the accessing the insulin sensitivity by Hyperinsulinemic Euglycemic Clamp, 葡萄糖耐量试验, 胰岛素耐量试验, CLAMS系统间接量热研究, 找出老鼠使用的是哪种燃料, NMR and DEXA scans to access the lean and fat mass in the body.
• 开发小鼠跑步机运动方案.
• My studies on diabetes have led me to create a thermography technique for my specific lab, 部门和外部客户.
• This technique involves using a specialized camera to detect levels of heat in an animal by imaging. 此外, the different colors in the image can be converted to tangible temperature values, which allow us to study the results with concrete values and numbers.
• This technique has been very useful to study the heat map of the mouse, which gives the surface temperature of the mouse near brown fat in the body.
• Such information can give us information on the activity of the mouse such as the amount of fat a mouse is burning, the activity of a tumor and how well the mouse can maintain its body temperature.