SUMMARY

• 12 + years of highly experienced SAS Developer /Analyst in health care, insurance, pharma and CRO industries.
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Connect, SAS/Enterprise Guide, SAS/Stat & SAS/Graph.
• Experienced with MS Excel functions that include working with large data sets, creating standardized reports, utilizing vLookups and advanced functions/ formulas, creating, using and interpreting pivot tables, filtering and formatting
• Worked with SAS and/or SQL creating queries, pulling large data sets and performed data manipulations/analysis.
• Oversaw the daily operations in SAS Enterprise Business Intelligence
• Worked on phase I Phase II and Phase III of clinical trials and their designs including open - labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.
• Worked on presenting data with different data visualization tools like JMP, Spotfire and Tableau
• Expertise in presenting data through standalone applications and building WebPages using asp.net, vb.net, JavaScript and HTML.
• Good knowledge of GCP, GPP and US FDA & CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well. Experienced in Preparing FDA E-submission ready reporting documentation including creating DDT’s, Transport files (XPORT format files).
• Experience involved in Statistics and contribution of end to end SAS programming activities data processing, data collection, quantitative and qualitative analysis (encompassing extracting data from Clinical trial into SAS as datasets to producing the reports viz.).
• Good understanding of regulatory requirements, ICH Guidelines, NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). This includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary (ISS & ISE) for FDA submission.
• Excellent skills in statistical analyses and modeling, familiar with common statistical methods for clinical research and Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials.
• Experience in survival analysis by using procedures like PROC LIFETEST (KAPLAN MIER), LIFEREG, PHREG, LOGISTIC.
• Experience in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs; Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development (SDD).
• Utilized SAS for manipulation and statistical analysis of large data sets to identify trends, relationships and statistical significance.
• Performed data analysis using for Regression and ANOVA
• Worked with procedures such as SQL, FREQ, SORT, REPORT and MEANS as per the requirements.
• Created reports in the style format (RTF, PDF and HTML) using ODS statements.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Worked extensively with MS-Excel, using pivot tables and creating OLAP cubes.
• Assisted in creating Stored Processes using SAS Enterprise Guide, Information Maps using Information Map Studio, Web Reports using Web Report Studio and Information Delivery Portals.
• Applied experimental design, test of significance, analysis of variance, multiple comparison techniques and data reduction to various data sets utilized.
• Utilized SAS for manipulation and statistical analysis of large data sets to identify trends, relationships and statistical significance.

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TECHNICAL SKILLS

SAS Skills: v 8.0/9.0/9.1/9.2 , SAS/BASE,SAS/STAT,SAS/MACROS,SAS/GRAPH,SAS/SQL, S-PLUS, SAS Enterprise Guide, SAS Enterprise Miner, SAS DI StudioSAS Web report studio, SAS procedures, SAS BI, Open CDISC validation.

Other Skills: SPSS, Spot fire, R, Qlikview, Sudaan, Strata, S-Plus, MINITAB,MATLAB, ETL tools,ODBC, health analytics using business intelligence tools, DataWarehousing, Data Mapping, SharePoint, Sigma Stat, Sigma Plot, MS Office(Power Point, Excel, Access, Word), MS Visio, MEDDRA, ICD-9,ICD-10COSTART,EPIC Bridges,HL7, Sarbanes-Oxley, HIPAA.

Databases: Oracle Clinical, MYSQL, MS SQL Server, MS Access, Oracle 11i, DB2.

Languages: C,C++, Visual Basic, VBScript, Java, JavaScript, Python, XML, T-SQL,SQL, PL/SQL, VB.NET, ASP.NET,PERL,HTML, PHP, Web CGI.

Operating Systems: Windows95, 98, NT/XP/2000, DOS, UNIX.

PROFESSIONAL EXPERIENCE

Sr. SAS Developer

Confidential - King of Prussia, PA

Responsibilities:

• Build standard SAS Macro library
• Mentor junior level SAS programmers
• Worked on platform for SAS Business Analytics typically client tier consisting of SAS Enterprise guide, SAS Add-in for Microsoft Office, SAS Information Map Studio, SAS OLAP Cube Studio and middle tier consisting of SAS Information Delivery Portal, SAS Web Report Studio, SAS Stored Process Web Application, SAS Content server and SAS BI dashboards.
• Worked on Programs for SAS data validation checks and listings to identify data discrepancies
• Programmed SAS checks to integrate and reconcile data from external sources .
• Review Case Report Forms and formatting of SAS datasets extracts for accuracy and consistency
• Provide programming support for Annual Safety Reports and Publications.
• Specifies and implements data flows and integrations between various clinical systems and ensures adequate testing and documentation..
• Defines the mapping of data collected in eCRFs or ECOA tools into standardized formats following the CDISC standard thus allowing pooled analyses.
• Supports the data exchange with other CR&D groups like Statistics, Pharmacometrics, Medical Writing & Disclosure etc.
• Collaborates with peers, data management, statistics and external service providers to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e.SDTM, ADaM, define.xml).
• Managed the review of related deliverables Supported CD staff in any data standards related questions supported data management and / or statistical programming and standards including standards metadata management

Sr. SAS Developer

Confidential

Responsibilities:

• Worked both production and QC programming of SDTM datasets, ADAM Efficacy and safety analysis datasets, tables, listings, and figures, for multiple clinical trials using SAS software.
• Expertise in creating eCRT packages - including Define.XML, SDTM Reviewers Guide and Annotated CRF for regulatory submissions (NDA).Prepared final eCTD documents to be submission ready using the pinnacle 21 runs.
• Worked on development ISS/ISE datasets and TLF’s.
• Working Knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards.
• Ensure that standards at a drug program level; integrates data across multiple studies or drug programs.
• Meeting the timelines or communicate proactively and effectively if timelines are at risk so that plans can beAdjusted
• Handled a moderate to large volume of complex tasks with minimal and ad-hoc requests with minimal guidance.
• Working knowledge of drug development process and clinical trials.

Sr. SAS Developer Tech Lead

Confidential

Responsibilities:

• Developing SAS code for tool development using SAS Macro and PROC SQL, with extensive and applied CDISC knowledge in SDTM and ADaM.
• Expertise in developing datasets with current knowledge, guidance and concepts of SDTM: ex: RELREC, SUPPQUAL, CO domain and generate Define.XML.
• Developed macros ex: co derive, BLFL for sdtm load.sas program, execute, test and deploy.
• Tech Lead for Primary development and unit testing of SDTM and ADAM detailed design and deployment.
• Used SDLC methodologies, from developing code till deployment.
• Reviewed and annotated eCRFs (Case Report Form)
• Assisted principal consultant to produce/validate eSubmission (eCRT, eCTD, define.xml) packages.
• Independently validated SDTM datasets, AdaM datasets, summary tables and graphs from other programmer

Senior SAS Developer

Confidential

Responsibilities:

• Created SAS programs for SDTM and ADAM datasets .
• Gathered study team requirements and translated them into technical specifications for SAS programs
• Created SDTM datasets for oncology study Lab, AE, DM, TU, TR, RS etc., from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
• Created and validated ADaM datasets from SDTM datasets as input, implementation guide and company standards.
• Created ADAM datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.
• Assisted with CDISC, SDTM and eCTD module case report tabulations
• Programs for SAS data validation checks and listings to identify data discrepancies
• Programmed SAS checks to integrate and reconcile data from external sources (including serious adverse events (SAE), lab results, ECGs, electronic patient records, medical devices and interactive voice response (IVR)) into the primary clinical database SAS datasets
• Review Case Report Forms and formatting of SAS datasets extracts for accuracy and consistency
• Provide programming support for Annual Safety Reports and Publications
• Build standard SAS Macro library
• Mentor junior level SAS programmers
• Provided Ad hoc statistical programming support
• Created Analysis datasets, Tables, Listings and graphs.