SUMMARY

• SAS Clinical Programmer with 8+ years of experience in design, analysis, program development and Quality Check (QC) validation in Pharmaceutical and Clinical Research Organizations.
• Hands on working experienced in Phase I - IV of clinical trials and various therapeutic areas including Oncology, Cardio Vascular, GI and Anti hypertensives.
• Extensive working knowledge in handling complex transformations using Base/SAS, SAS/STAT, SAS/ Macros, SAS/SQL, and SAS/Graphs
• Experience in creation of annotated CRF by using Adobe professional.
• Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
• Work in tandem with Biostatistics and Data Management member on various clinical projects.
• Experience in creation of SDTM datasets and validated those datasets.
• Experience with CDISC guidelines while producing Safety and Efficacy SDTM and ADaM Datasets, Tables, listing and Graphs.
• Experience in writing SDTM Mapping specifications and ADaM Specifications
• Experience in Validating the datasets and Tables by using Double programming Technique and compliance checks by using Pinnacle 21
• Good Knowledge on RECIST Criteria (1.0&1.1) and survival Analysis
• Involved in FDA submissions by reviewing define.xml
• Proficient in using SAS/ODS to create Ad-hoc RTF, PDF, and Listing output reports.
• Wrote and reviewed specifications for modifying existing Standard Macros
• Programmed Edit Checks programs to create reports for data cleaning and data validation.
• Experience in creation of graphs by using PROC SGPLOT
• Good Knowledge in statistical procedures like PROC-PHREG, PROC GLM, PROC ANNOVA, PROC T-TEST, PROC LIFETEST.
• Hands on working experience in Medidata Rave to optimize Clinical process to ensure quality, integrity for accurate implementation with study endpoints.
• Worked with Various Deliverables like DMC, IA (Interim Analysis)
• Ability to work in a cross-platform environment that includes Windows and UNIX Operating Systems
• Excellent communication skills, good at multi-tasking and a good team player meeting timeline.

TECHNICAL SKILLS

Statistical Software: SAS v9/v9.2, SPSS

SAS Tools: SASV8, V9, SAS/BASE, SAS/SQL, SAS/Access, SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/Access, SAS/ REPORT, SAS/ODS.

Languages: HTML, SQL, XML

Databases: MS Access, SQL, SAS Clinical

Office Tools: MS OFFICE - Word Excel, Power Point

Operating Systems: Windows / XP, Vista, UNIX, Linux, Mac

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential, Branchburg, NJ

Responsibilities:

• By Providing statistical programming support for clinical trial data reporting under the general guidance of a principal biostatistician, biostatistician, development team and clinical data management team.
• Develop SAS programs that generate tables, listings and figures and derived datasets that summarize results for clinical trials.
• Performing validation and Quality Control on final reports by communicating with programming and statistics leads, data managers and other team members.
• Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
• Proactively adapt to the changing business and technology landscape of SAS programming skills.
• Develop SDTM, ADAM mapping techniques from existing data dictionaries following best practices and SOPs.
• Develop and process queries using SAS/ Enterprise Guide, using data stored in default collection systems (DMCS) DB2 files.
• Analyze root causes of performance issues and provide corrective actions.
• Suggest new techniques to improve efficiency statistical analysis.
• Contribute to the development and implementation of programming and reporting standards.
• Contribute to the development of a macro library.
• Work closely with data management to assure data quality and consistency.
• Provide occasional analytical support under the supervision of a biostatistician.
• These efforts must meet company objectives and satisfy regulatory GCP and ICH requirements and guidelines.
• Perform Quality Control on final reports.
• Provide QC and validation reports.
• Communicate with programming and statistics leads, data managers and other team members.
• Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
• Work in tandem with Biostatistics and Data Management member on various clinical projects.
• Experience in Validating the datasets and Tables by using Double programming Technique and compliance checks by using Pinnacle 21.
• Involved in FDA submissions by reviewing define.xml.
• Hands on working experience in Medidata Rave to optimize Clinical process to ensure quality, integrity for accurate implementation with study endpoints.

Environment: SAS 9.2/9.1.3 SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, UNIX and Windows, DB2, MS Excel/Word/PowerPoint

Clinical SAS Programmer

Confidential, Rochester MN

Responsibilities:

• Experience in creation of annotated CRF with SDTM variables.
• Created and reviewed SDTM and ADaM mapping specifications.
• Worked extensively on various SDTM domains and their SUPPQUAL and updated the Specs and Program status respectively.
• Worked on SDTM domains based associated person SDTM IG (AP).
• Worked on Trial Design Domains for early and late phase.
• Mapped current versions of MeDRA and WHO-DRUG dictionaries with AE and CM datasets respectively.
• Mainline responsibility for working on different clinical trials data like Demographic, Adverse Event (AE), Laboratory-chemistry/Hematology/Urine analysis,Vital signs, and Disposition etc.
• Developed and validated Oncology specific domains Tumor Identification (TU), Tumor Results (TR) and Disease Response (RS).
• Generated ADaM datasets and produced Tables, Listings and Graphs (TLG) programming based on Mockup shells
• Performed open-CDISC validation on Performed open-CDISC validation on SDTM, ADaM and Define.XML.
• Involved in FDA submissions and developed numerous Ad Hoc reports as required by medical writers and FDA.
• Worked on unblinding process for different therapeutic areas.
• Created and reviewed Define.XML and SDRG.
• Modified existing Macros as per the requirement.
• Flexible working with clinical data management by using Medidata Rave to optimize Clinical process to ensure quality, agility, integrity for accurate implementation with study endpoints.
• Act as POC/back up lead for small team projects in providing technical and process-related guidance to team members and leading sub-team project with minimal or no supervision.

Environment: UNIX, SAS ODS, SDTM etc.

Clinical SAS Programmer

Confidential, Morrisville, NC

Responsibilities:

• Clinical data analysis from raw data tables and generation of SAS data sets, performing analysis and generating reports, Tables, Listings, Summaries and Graphs as per the Statistical Analysis Plan and program specification document.
• Cleaning and management of raw clinical data.
• Interacting closely with other team members to develop a good understanding of clinical protocols, arriving at clean data for statistical analysis and derivation of statistically meaningful conclusions.
• Performing the tasks assigned using standard operating procedures (SOPs) as provided by the department.
• Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
• Work in tandem with Biostatistics and Data Management member on various clinical projects
• CRF annotations as per the specs provided.
• SDTM mapping and datasets generation for various domains such as Demographics, Exposure, Adverse Events, Medical History, Lab, Concomitant Medications etc.
• Performing descriptive statistics procedures using PROC MEANS and PROC FREQ.
• Creation of listings, tables, graphs, and reports to summarize the final analysis results in a clear, concise, and presentable format.
• Involved as a support to develop SDTM mapping specs to generate CDISC compliant SDTM datasets starting from raw source data tables.
• Validation and transformation of datasets, tables, listings, and figures as per client assignment specifications.
• Generating customized reports using PROC REPORT and SAS/ODS facility.
• Managing assignments to meet timelines and producing high quality deliverables with the documentation of all efforts and results.

SAS Clinical Programmer/Analyst

Confidential, Chicago, IL

Responsibilities:

• Understanding of study documents and CRF annotations and been part of team in reviewing of Protocols and Statistical Analysis Plan (SAP)
• Created SDTM domains like AE, EX, LB, CM, MH…etc. based on SDTM mapping specifications and validated them.
• Created ADaM domains like ADLB, ADAE., etc. based on ADaM specifications and validated them.
• Worked on ADaM Dataset derivations like Treatment Emergent Adverse Event, Visit Windowing, Baseline, DType (LOCF) based on SAP
• Converting Local labs data into central labs by using Unit Conversion dataset
• Created and Validated Safety and Efficacy related analysis datasets, Summary tables, Listings and Graphs (TLG’S)
• Worked with clinical data management team for creating annotated CRF. Created SAS data sets from raw clinical data sets of clinical trials.
• Extracted data from various data sources like Oracle Clinical 5.0.1 etc. and converted external data into SAS raw datasets
• Developed Edit checks for different studies and in reporting those issues to the data manager in excel sheet.
• Experience in importing and exporting complex internal data to and from Microsoft Excel and Microsoft Access using PROC IMPORT and PROC EXPORT
• Produced Ad-hoc reports, listings, tables using Proc Report Validated the generated reports according to QC tracking sheet.
• Working on many other ADHOC urgent priority tables request from other team on daily basis.
• Carried out all activities according to SOPs working within the framework of the Quality Management System and to Good Clinical Practices (GCPs)

Environment: UNIX, SAS ODS, SDTM etc.

SAS Programmer/Analyst

Confidential

Responsibilities:

• Worked regularly on extracting data from oracle clinical database through SAS/ACCESS and SQL pass through facility.
• Created datasets by processing the raw data in text files, comma separated files, and Excel spread sheets using INFILE Statement with DSD, DLM, and MISSOVER options and created SAS Macros and Graphs.
• Generation of SDTM datasets and validating them in accordance with CDISC standards for FDA from raw SAS Datasets by developing SDTM mapping specifications.
• Performed data validation by using Proc freq, proc means.
• Generated summary tables, listing, graphs using SAS Procedures and validated them according to the Protocol and SAP Mock shells.
• Generated reports in RTF, PDF, HTML and MS Excel formatted files using SAS/ODS.
• Written complex queries, sub queries and nested queries to get the data from different sources by using proc SQL.
• Extensively used SAS/MACRO for creating macro variables and macro programs to modify existing SAS program for ease of modification while maintaining consistency of results and developed SAS/ Macros for generic coding and reusable modules.

Environment: SAS/BASE, SAS/MACROS, SAS/ACCESS, DB2, SAS/STAT, SAS ODS, Windows.