SUMMARY

• Over 8 Years of experience in Clinical domain with SAS in Windows,and Unix environment.
• Having knowledge of clinical trials in various therapeutic areas such as Oncology, Immunology, Diabetology, Genito - Urinary and Hematology.
• Having working knowledge of different phases(Phase I to IV) of clinical trials data like demographic data, Pharmacokinetics, adverse event, laboratory data, physical and vital signs etc.
• Worked with senior biostatisticians and data managers for data analysis, report generation and regulatory submissions.
• Experience on SAS product installation in UNIX/AIX environment.
• Solid experience with SAS Base Programming, SAS Reporting Tools and SAS Macros
• Experience planning, administration, and management of necessary services, functions and operations in SAS programming environment
• Experienced with Facets Data Model, Data Dictionary, Table Structures, Database Object Naming Conventions, Database procedures, Database triggers, Referential Integrity, Batch System Architecture
• Experience in using data steps in SAS implementation, SAS for creating, maintaining and manipulating datasets
• Experience in Facets including configuration, validating, auditing, and data analysis
• Used various SAS procedures such as Tabulate, Univariate, SQL, Freq, Means, TTest, Anova, Compare, Sort, Transpose, Report, MIXED, GLM etc.
• Has experience in writing stored procedures and code to implement, extract, transform, and load methodologies.
• Responsible for transferring knowledge of the Trizetto Facets data model to analysts with no experience and also for transferring web services, accumulator, and authorization knowledge to resources experienced with Facets
• Responsible for transferring knowledge of the Trizetto Facets data model to analysts with no experience and also for transferring web services, accumulator, and authorization knowledge to resources experienced with Facets
• Design, implement, test, debug database stored procedures and complex queries to extract, calculate, or manipulate information.
• Has worked for Health care products like Facets and QNXT.
• Expert in working with tools like Facets data model
• Used various SAS functions like, SCAN, SUBSTR, INDEX, INPUT, PUT, ROUND, MDY, etc.
• Involved in writing SAS programs based RAPs (SAP and Programming algorithem) using SAS to generate analysis datasets, statistical reports, listings, tables and graphs for analysis of clinical data.
• Expertize in combining the data using SET, MERGE and SQL, and manipulating data using the statements RETAIN, ARRAY, IF, DO, First.var and Last.var.
• Excellent experience in exporting SAS Results to different formats, such as HTML, RTF, PDF using SAS/ODS for reporting and presentation
• Having knowledge on CDISC (SDTM), Enterprise Storage Management and AIX Admin environment.
• Complete analysis of Facets for benefits and medical definitions.
• Document benefits and medical definitions in Facets.
• Experienced on Oracle Life Science Hub as Life Science Programmer.
• Able to work in a fast paced environment and meet deadlines.
• Capable of adopting new domains, technologies, concepts and environments.
• Participated in preparing Standard Operating Procedures (SOP) and Process flow.
• Knowledge in FDA regulations, 21 CFR Part 11, ICH and GCP guidelines.

TECHNICAL SKILLS

SAS Skills: BASE SAS, SAS/MACRO, SAS/Stat, SAS/Graph, SAS/SQL and SAS/ODS

Ms-Office tools: Word, Excel and Power Point

Operating Systems: MS-Windows 98/NT/2000 and Unix

Other Tools: Oracle LSH, Facets

PROFESSIONAL EXPERIENCE

Confidential, East Hanover, NJ

Sr. SAS Developer

Responsibilities:

• Extracting data from different sources such as Oracle Clinical, third party data sources using Oracle LSH.
• Worked on Custom work orders on Facets
• Designing technical documentation depicting standard operating procedure and which is critical for the validation process as and when required for various environment QA and products like Facets
• Pre-Conforming data by merge or Union the different views.
• Confirming data by converting non standard variable names to CDISC Standards.
• Post-Conforming the data to be used for statistical reporting.
• Communicating with different study teams personnel like Data Manager, Database Programmer, CRO personnel, Clinical Trial Head and Third Party vendors.
• Leading all programming activities for in-house and out-sourced trials.
• Locally coordinate and take responsibility for Oncology trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I clinical trials to support program programmers and statistician in project level activities.
• Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I clinical trials and submission activities.
• Review the Protocol, CRFs and Statistical Analysis Plan.
• Develop specifications for analysis datasets and pooled datasets.
• Debelop macros using SAS for analysis datasets, pooled datasets, listings, tables, and figures as per specification for phase I clinical trials and for pooled analysis with high quality and within milestones.
• Develop standard macros for standart tables and listings using SAS programming.
• Create macros for data validation by checking data distribution and comparison to standard data, writing double codes to check the consistency of statistical values generated as part of quality procedure.
• Provide inputs on process improvement initiatives and participate in non-clinical project activities with support from Group Head.
• Co-ordinate with CRO for outsourced trials.
• Co-ordinate with the Clinical Team, Clinical Data Manager and Statistician.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/Graph, SAS/SQL, SAS implementation, Oracle Clinical, Oracle LSH, PL/SQL, system management and UNIX Shell Scripting .

Confidential

Sr. SAS Developer

Responsibilities:

• Leading all programming activities for in-house and out-sourced trials.
• Locally coordinate and take responsibility for Oncology trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I clinical trials to support program programmers and statistician in project level activities.
• Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I clinical trials and submission activities.
• Review the Protocol, CRFs and Statistical Analysis Plan.
• In consultation with the statistician, develop specifications for analysis datasets and pooled datasets.
• Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I clinical trials and for pooled analysis with high quality and within milestones.
• Create macros for data validation by checking data distribution and comparison to standard data, writing double codes to check the consistency of statistical values generated as part of quality procedure.
• Provide input on process improvement initiatives and participate in non-clinical project activities with support from Group Head.
• Co-ordinate with CRO for outsourced trials.
• Co-ordinate with the Clinical Team, Clinical Data Manager and Statistician.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/Graph, SAS/SQL, Windows NT/2000 and UNIX admin environment.

Confidential

Project Lead

Responsibilities:

• Review the Protocol, CRFs and Statistical Analysis Plan(SAP)
• Provide inputs to SAP.
• Generate, Review and Approve programming algorithem for analysis datasets and TLFs.
• Generate and Reviewing the results generated by team.
• Coordinate with Data Manager, Biostatistican and client.
• Deliver the quality results within the timelines.
• Make sure that programming is done as per SOP.
• Provide input on process improvement initiatives and participate in non-clinical project activities with support from manager.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/Graph, SAS/SQL and Windows NT/2000.

Confidential

Sr. SAS Developer

Responsibilities:

• Review Protocol, CRFs and Statistical Analysis Plan(SAP)
• Provide inputs to SAP.
• Extract data from OC database and make sure that data was extracted properly.
• Identify data issues and communicate to data manger.
• Develop specification for analysis data sets.
• Create analysis datasets and generate TLFs as per SAP and specification using CDARS tool(SAS programming).
• Validate analysis datasets and TLFs using SAS programming.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/Graph, SAS/SQL, Windows NT/2000 and UNIX.

Confidential

SAS Developer

Responsibilities:

• Review the Protocol, CRFs and Statistical Analysis Plan(SAP)
• Provide inputs to SAP.
• Identify the data issues and communicate to team lead.
• Generate and validate TLFs as per SAP using SAS programming.
• Participate in study team meetings.

Environment: SAS, SAS/BASE, SAS/MACROS, SAS/Graph, Oracle, PL/SQL and Windows NT/2000