Objective

• To obtain a senior SAS programmer/data analyst position in pharmaceutical/biotechnology or Healthcare area industry with extensive and solid SAS programming and clinical trial data analysis experience and Relational Database Development and Implementation

SUMMARY

• 8 years of extensive experience in SAS programming, Data analysis and Management generating Reports, Tables, Listings and Graphs and Database Design, Development and Implementation and Reporting and Modeling.
• 8 years of solid experience in phase I - IV clinical trials
• Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials
• Proficient with SQL, PL/SQL, C++, C, JAVA, VB, XML, HTML, JavaScript Programming Languages and UNIX SHELL.
• Extensive Experience in Microsoft Office Suite, Include Microsoft Word, Excel, Access, PowerPoint, and Outlook.
• Proficient in understanding of Data Mapping, Data Modeling, Entity Relationship, Diagram, Normalization, Relational DBMS, Object-Oriented DBMS, Multidimensional DBMS in Oracle Database, SQL Server, and Microsoft Access Database.
• Extensive experience in using various SAS tools like SAS/BASE, SAS/ODS, SAS/STAT, SAS/GRAPH, SAS/MACROS, SAS/SQL in Windows and UNIX and Linux Environment.
• Professional Experience with Import Various External Data Files(excel, CSV, ASCII, and XML) into SAS Dataset/SAS Library by Using SAS/INFILE, SAS/SQL, SAS/Access and SAS/IMPORT to Connect SAS System with Relational Database Management Systems to Retrieve Data and Create SAS Datasets
• Excellent work experience in generating reports, tables, listings, and graphs as well as data manipulation and dataset preparation: cleansing, merging, combining, splitting, and validating by using SAS statements FORMAT/INFORMAT, MERGE, SUBSET and procedures PROC SORT, PROC TRANPOSE, PROC APPEND and PROC RANK according to Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Expertise in producing the customized graphs by employing SAS/GRAPH procedures PROC GPLOT, PROC GCHART and PROC GREPLAY.
• Solid working experience in Data Manipulations using SAS procedures such as Array, Do Loop, PROC SQL, MERGE, PROC SORT, PROC TRANSPOSE, etc.
• Comprehensive knowledge of advanced Statistic Analysis Method including regression analysis(Proc Reg), Analysis of variance(Proc Anova), Analysis of categorical data(Proc Logistic) Multivariate Analysis(Proc Glm), Sampling and Data Modeling for performing exploratory analyses and PROC GENMOD,PROC PHREG, etc.
• High proficiency in creating output files in a variety of formats including EXCEL, RTF,HTML and PDF etc using SAS/ODS and SAS/EXPORT for reporting and presentation
• Strong programming skills in analysis, design, development, implementation and debug SAS MACRO to access, extract, modify, merge and analyze clinical data and output statistical analysis into files, tables, listings and graphs
• Proficient in Debugging and Validation skills.
• Extensive experience and skill in modifying existing SAS programs, edit checks output to ensure quality of deliverables.
• Extensive Knowledge and Excellent Practice in FDA 21 CFR Part 11 Regulations from clinical trials of Phase I through III and regulations for IND and NDA submission.
• Extensive experience in implementing CDISC SDTM and ADAM standards, strong knowledge of SDTM involved in analyzing data, writing and updating Standard Operating Procedures (SOP) for reviews and approvals.
• Experience in programming and generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for submission.
• Extensive knowledge and experience in Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data and Efficacy related data.
• Excellent Presentation Skills in Using Microsoft PowerPoint, SAS Table, SAS Graph
• Excellent skill in critical thinking, problem solving, and decision making skills to dismantle complex problems and optimize solutions with excellent organizational and interpersonal skills
• Ability to effectively organize and manage multiple assignments to meet deadlines as a quick and highly self-motivated individual and excellent team player under work pressure in validation and testing complex scenarios and projects and in the maintenance of Quality Standards in Projects

TECHNICAL SKILLS

SAS Tools: SAS/Base, SAS/Access, SAS/SQL, SAS/Macros, SAS/Graph, SAS/Stat, SAS/ODS

Databases: Microsoft SQL Server, Oracle, MySQL, Power Builder, Visual FoxPro, MS Access

Operating Systems: Windows 2000/NT/XP/ Confidential, UNIX, Linux, Mac OS

Networking: TCP/IP, LAN, and FTP

Programming Languages: C, C++, JAVA, VB, XML, HTML, JavaScript, SQL, ABEL

Software: Microsoft Office (Word, Access, Excel, PowerPoint, SharePoint, Visio), MS Outlook, Adobe Acrobat, AutoCAD, Visual Studio

PROFESSIONAL EXPERIENCE

Senior SAS Clinical Programmer

Confidential, Pennington, NJ

Responsibilities:

• Prepared analysis data sets on CDISC standard (SDTM, ADAM)
• Developed and QA e-sub package such as reviewerguide.pdf, define.xml, define.pdf on SDTM and ADAM
• Worked on oncology submission assignment on US, EU and JAP for different studies focus on Phase 3 level mostly
• Worked on integration for efficacy and safety
• Worked on AD-HOC requests
• Developed codes for datasets and TLFs on risk management plan, DSUR and something else.
• Worked on FDA requests after submission

Environment: SAS UNIX, SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc.

Senior SAS Clinical Programmer

Confidential, Danbury, CT

Responsibilities:

• Developed, modified, validated and implemented SAS programming according to Statistical Analysis Plan (SAP).
• Developed Development Safety Update Report (DSUR)
• Developed CDISC standard codes according to FDA guideline for projects and used open cdisc validator to qc and wrote specs and ADS plan
• Developed codes for publications such as MA support
• Worked on safety/efficacy analysis datasets such as time to events dataset
• Did validation on standard CDISC or non-CDISC format ads and TLF
• Worked on ISS project to create ads and table listing such as disposition of patients and adverse events tables
• Worked on AD-HOC requests
• Worked on e-submission project such as generate ads, wrote define excel, create define.xml and xpt files
• Worked both on trial and project level projects
• Organized datasets for statistical analysis by merging, combining, splitting, and coding, and performed edit-check for datasets to assure the quality of the datasets.
• Prepared customized analysis datasets for specific reporting needs.
• Wrote code using SAS/Base and SAS/Macros to extract clean and validate data
• Directed customized SAS outputs to RTF and HTML files through Output Delivery System (ODS) facility.
• Validated programming output with other programmers’ output in SAP.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access
• Built Macros to produce customized tables. In these Micros, DATA STEP and various procedures: PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC MIXED, and PROC FORMAT were applied to generate various data tables, patient data listings and reports according statistical analysis plan.

Environment: SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc. Windows XP, Confidential, Windows Server, Rage

Senior SAS Programmer

Confidential

Responsibilities:

• Provided statistical support, analyses, and reports for HIV/AIDS Project in the Office of CDC. Provided SAS code with detailed documentation and maintain SAS log and copy of outputs for jurisdictions.
• Provided scientific support by assisting epidemiologists in analysis and presentation of data in reports, at scientific meetings, and publication in peer-reviewed scientific journals of multi city comparisons.
• Provided data support for the project from cdc databases
• Meet with CDC technical contact and programming staff to determine appropriate work assignments, including: data analyses, database manipulations, evaluations, etc
• Designed and writes computer code in the Statistical Analysis System (SAS) computer software language to support analysis of project using the cdc databases for the different jurisdictions
• Maintained comprehensive SAS skills in order to meet the programming needs for project
• Checked accuracy of output and output datasets against other sources.
• Provided reports and support for others using cdc data to produce special purpose reports of the project by deadlines specified.
• Maintained a library of SAS code used in report production.
• Develop standards for programming and data management.
• Developed and maintained effective working relationship with programmers and data management staff in CDC and jurisdictions.
• Participated in preparation of recommendations for revision and changes in data quality review.
• Worked closely with statisticians, data managers, and active participation in weekly and monthly meetings.
• Reviewed, collected, managed, processed, analyzed and interpreted safety data collected during clinical trials research project
• Reviewed study protocols, and provided SAS programming support for clinical study
• Assisted project participants to improve case finding, data completeness, evaluate surveillance performance, data analysis, and dissemination of surveillance data analysis results.
• Conducted data quality and evaluation activities according to CDC standards and ancillary surveillance analyses.
• Tested program logic to support analysis of project for jurisdictions and develop standards for programming and data management.
• Visited jurisdictions to do support purpose.
• Developed routine SAS macros for jurisdiction for quarterly run.
• Performed quality assurance procedures, validation of SAS programs.
• Performed data cleansing, edit check, validation for TLG.
• Worked on different surveillance data source in CDC.

Environment: SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, PROC REPORT, PROC TABULATE, etc., Windows

SAS Programmer

Confidential, Dallas, TX

Responsibilities:

• Used SAS and SAS Tools for pre-processing data, data analysis, statistical analysis, and created permanent formatted SAS data sets.
• Performed data Extraction: Convert raw data sets into SAS data sets.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access.
• Used sorting and merging techniques on the input data sets for Data Preparation, to get the required output and then writing the code using SAS tools. SAS/ Macro was extensively used and facility to write weekly and monthly reports.
• Used SAS for pre-processing data, SQL queries, data analysis, generating reports, and statistical analyses.
• Developed routine SAS macros to create tables, graphs and listings (T/F/L) for inclusion in clinical study reports and regulatory submissions and maintained existing ones. Prepared clinical data listings and summaries for statistical analysis.
• Developed quality customized reports using PROC REPORT, PROC TABULATE PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE and used PROC COMPARE to validate reports. Developed case report forms, data validations, and data quality plans.
• Designed statistical summary tables, graphs and patient data listings using base SAS procedures like Proc Summary, Proc Tabulate and SAS/Graph.
• Developed reports: From the processed data, several reports were generated and also converted the data sent to the client.
• Developed documentation: The process of each project is documented accordingly for future reference.
• Implemented study specific procedures compliant with regulatory and internal procedures and requirements.
• Designed, documented, tested, implemented and managed clinical data. Reviewed, clarified and reported systems for clinical studies. Managed designated project timelines and prioritization of tasks.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Graph, UNIX and Windows