SUMMARY

• Overall 12+years and 7+ years of working experience in the field of Clinical SAS and scientist in Biotechnology/Pharmaceuticals/Academia.
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH.
• Extensive experience on using SQL, PROCSQL, SAS Database, and many other SAS facilities, such as Import/Export.
• Experience in therapeutic areas like Central Nervous System, Cardiology, Oncology, Hematology, Virology, and Epidemiology.
• Worked with Statisticians in analyzing the Health Care Data, Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using Import techniques.
• Experience in developing Macros using SAS procedures.
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating & documenting tables, listings and graphs for clinical study reports.
• Excellent knowledge of SAS Procedures: PROC FREQ, PROC UNIVARIATE, PROC REG, PROCTTEST, PROC ANOVA.
• Expertise in usingSAS/GRAPH to produce Graphs by employingSASprocedures such as ProcGplot and ProcGchart.
• Generated reports using PROC REPORT, DATA NULL and PROC TABULATE for customized report writing.
• Experience in producing RTF, PDF, and HTML files using SAS ODS.
• Knowledge of Clinical Terminology and regulatory Guidelines.
• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Vitals, Laboratory Data.
• Experience in programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Working Experience of Clinical Trial Phases, Clinical protocols/ CRF’s/Annotated CRF’s, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Extensive experience in disease research and strong knowledge of modern disease biology, both theory and lab experimentation with innovative professionalism.
• Good Experienced on handling, maintaining, & calibrating of different kind of Instruments such as Confocal and Fluorescence Microscope, SiRNA(Dharmacon) RNA/DNA extraction, plasmid minipreps, Endo - free plasmid maxipreps, transfection in mammalian cells, semi quantitative RT PCR, Real time PCR by Light Cyclear, cloning, transformation, DNA sequencing, Northern blots, immunoprecipitation, densitometric analysis of protein gel, ChIP assay and different Medical Devices.
• Strong communication skills and can work well in a team.

TECHNICAL SKILLS

SAS Tools: Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/Enterprise Guide, SAS/Enterprise Miner

Databases: Oracle Clinical, Microsoft-SQL.

Software Packages: MS Office, WordPerfect, Excel

Operating System: Windows 98, Windows XP, Windows Vista, UNIX.

PROFESSIONAL EXPERIENCE

Confidential, MI

SAS programmer

Responsibilities:

• Developed SAS programs to generate Provider Profiles for the Eligibility, Medical Claims, Pharmacy Claims, and Clinical Quality Reports to meet the Standards in addition to the adhoc programming for several departments from within and outside the organization.
• We have been using extensive SAS/BASE, SAS/CONNECT, SAS/SQL, SAS/ODS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL and SAS/MACROS for programming. The processing of the data and the manipulation are done on the server. Then later the data is downloaded to the local pc, which is a WINDOWS Operating System. The procedures such as Proc Tabulate, Proc Summary or Proc Report are used to generate these reports and outputted to Datasets, MS-EXCEL, MS-ACCESS Databases, and HTML and Delimited text files depending upon the requirement.
• Modified standard programs to generate data sets for statistical data analysis, generate listings, summaries.
• Used SAS Macros extensively in the creation of new programs as well as modification of existing programs to improve ease and consistency of result.
• Analyzed large data sets consisting of millions of records.
• Generated analysis reports, graphs using SAS/Reports.
• Analyzed data using SAS/Stat procedures.
• Involved in documentation of design, Code and Reports for handling over the project.
• Involved in delivering Output using ODS (Output Delivery System).
• Used base SAS procedures FREQ, TABULATE, and MEANS to validate current results with expected results.
• Created reports in a form of text as well as Graphical using SAS/Graph, SAS/Reports and Base SAS procedures
• Performed quality assurance procedures of other programmers’ work, validation of SAS programs, and debug complex programming code.
• Extensively used PROC FREQ, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC CONTENTS, PROC COMPARE, PROC REPORT, and PROC UNIVARIATE.

Environment: SAS 9.3, SAS/BASE, SAS/ODS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ACCESS, UNIX and Windows, MS Excel/Word/PowerPoint

Confidential, Ann arbor, MI

Clinical SAS Programmer

Responsibilities:

• Produced analysis datasets and generated tables, listings, and graphs using SAS.
• Wrote SAS listings and tables in PDF, RTF, CGM formats using SAS ODS.
• Developed advanced MACROs with high programming efficiency; strong programming and problem-solving skills.
• Responsible for manipulating, transferring and managing data in SAS.
• Review CRF’s to ensure consistency with protocol and adequacy to collect the data to meet the objectives defined in the statistical section of the protocol.
• Modify the ADaM file specification (Variable Definition) based on Statistical Analysis Document (SAP, DPS, mockups etc.)
• Reviews the Statistical Analysis Plan (SAP), TFL Shells, Dataset specifications, the annotated CRF to generate an annotated TFL shell to aid programming.
• Executes analyses specified in the protocol or the Statistical Analysis Plan (SAP) under the guidance of the project statistician.
• Utilized BASE SAS, SAS STAT and SAS MACROS for writing, editing, validating, and debugging code.
• Review and provide inputs for essential trial documents such as protocol, CRF, Data Management Plan (DMP), Statistical Analysis Plan (SAP).
• Mentors junior programmers.
• Participates in protocol team and some project team interactions.
• Experience in extracting the data from Oracle and SQL Server databases efficiently.
• Debugging SAS code, compiling errors, review SAS code.
• Used SAS/GRAPH to present data analysis using PROC (Such as GPLOT, GCHART, UNIVARIATE and FREQ.)
• Assisted fellow programmers in validation, edit checks, and data review listings.
• Utilized SAS/ACCESS to gather data from RDBMS such as ORACLE, and data sources extracted into the ORACLE tables were later extracted into the ODS.
• Analyzed safety and efficacy data from Phase I, II and III clinical trials.
• Applied SAS/STAT to present results in BAR charts, LINE plots, and SCATTER plots.
• Extensively used various procedures such as PROC (Such as PRINT, SQL, UNIVARIATE, MEANS, FREQ, TABULATE, REPORT, SUMMARY, GPLOT, GLM and IMPORT.)
• Developed efficient, well-documented and readily comprehensible SAS code using SAS/ Base and SAS/ Macro facility.
• Worked with Statisticians in generating SAS analysis datasets, production of data listings, summary tables, and statistical analysis
• Used CDISC knowledge to develop SDTM datasets for various domains and ADaM analysis datasets.
• Worked in multi-disciplinary teams closely with statisticians, medical writers, and data managers.
• Document SOP, work instruction, processes and standards as per FDA regulations 21 CFR part 11.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/GRAPH, MS Access, Windows, Excel.

Confidential, PA

CDM Scientist/ SAS programmer Analyst

Responsibilities:

• As a Clinical Data Management (CDM) Scientist primarily focused on different Pre-Clinical and Clinical studies for Cardiovascular Diseases and Oncology Domain.
• Provide Database, Analytical and Statistical programming support to research protocols.
• Coordinate Program, Analyze, and Evaluate Clinical Data Management using the SAS 9.3 Programming Language in Windows and Unix (Oracle Solaris) via VNC x11 and WinSCP along with different Databases as; Clin-Plus, Oracle, SyBase and Access.
• Generate and maintain administrative and statistical reports to be run on a Periodic or Ad Hoc basis and Clinical Data Management by CPDM v3.3.
• Assist Principal Investigators and Scientists in retrieving and incorporating information from multiple data source using SAS, SQL or other Query tools.
• Participate in different Statistical Modeling Research protocols on in-house Clinical Data Management software package as a CDM Scientist.
• Develop, Review and Participate in the following:-
• Data Management Plans and Data use agreements.
• Data Entry Instructions.
• Standard Operating Procedures.
• Case Report Forms and Case Report Form Annotation.
• Other Department and Protocol related Documentation.
• Statistical Predictive Modeling.
• Working experience as a QA and BA as per business needs.
• Provide written Documentation to include description of pertinent Data sets, Formats, and Structures. Insure that Data sets are complete and correct.
• Adheres to a Policy of Strict Confidentiality concerning all Documents, Data, and Information maintained within the Department.
• Adheres to Department Standard Operating Procedures for all Data Management responsibilities.
• Knowledge of the SAS 9.3 Programming Language, Especially Basic SAS Procedures as; CIMPORT, COMPARE, CONTENTS, CPORT, EXPORT, FORMAT, FREQ, IMPORT, MEANS or UNIVARIATE, PRINT, REPORT, SORT, SQL, CDISC (SDTM & ADaM) and the DATA step etc.
• Ability to perform programming tasks in a SAS/Oracle environment.
• Experience in handling Large Data sets, Awareness of Data Quality issues, and familiarity with programming in a research environment.
• Performs other duties as required.
• The publication from department as a co-author are listed below:
• Xue Li, Chowdhury I, Walter J. Koch, Arthur M. Feldman et al. (2011) Controlled and Cardiac-Restricted Overexpression of the Arginine Vasopressin V1A Receptor Causes Reversible left Ventricular dysfunction Through Gaq-Mediated Cell Signaling. Circulation, 124(5):

Environment: SAS 9.3, SAS/BASE, SAS/MACROS, SAS/GRAPH, Clin-Trial, PL/SQL, Molecular & Cell biology technique

Confidential, NY

SAS programmer Consultant

Responsibilities:

• Worked with clinical research staff and study group to provide SAS programming support for Clinical Trial projects.
• Assisted with analysis planning including review of table and listing mockups as well as dataset analysis as per requirements.
• Validated programming output with other programmers output and mockups in Statistical Analysis Plan using PROC COMPARE.
• Used DATA step to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms (CRF’s).
• Used various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate various data tables, Confidential t data listings and reports according to Statistical Analysis Plan (SAP).
• Contributed to Integrated Summary of Safety (ISS) analysis.
• Created tables, graphs and listings (TGL’s) for inclusion in clinical study reports and regulatory submissions and also maintained existing ones by using SAS MACROS.
• Ensured that analysis data and programming codes met the regulatory and company standards and were consistently structured to permit efficient programming and reporting.
• Prepared detailed analysis plan from study protocols with other biostatisticians.
• Wrote Customized Safety and Efficacy Reports directing SAS output to RTF and HTML files using Output Delivery System (ODS) facility.

Environment: Windows, SAS 9.2, SAS/BASE, SAS/STAT, SAS/MACROS, SAS/ODS

Confidential, MD

SAS Programmer/ Analyst

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection andclinicaldata analysis. Analyzed Phase I to Phase IV ClinicalTrials data.
• Performed analysis, wroteSAScode for data management and reporting and performed validation, including testingSAScode.
• Preparedclinicaldata listings and summaries for statistical analysis and analyzedclinicaldata usingSASsystem.
• Developed reports usingPROC REPORTS, PROC TABULATEandDATA NULL .
• Developed efficient, well-documented, readily comprehensible and modifiableSAScode usingSAS/BASEandSAS/MACROfacility.
• UsedSASfor pre-processing data, SQL queries, data analysis, generating reports, graphs and statistical analyses.
• Was involved inclinicaltrials programming of data tables and listings for reporting on safety and efficacy.
• Produced customized reports by usingPROC TABULATE, REPORT and SUMMARYand also provided descriptive statistics usingPROC Means, Frequency,andUnivariate.

Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, DB2, SQL Server, MS Excel, WINDOWS 2000, UNIX

Confidential, VA

SAS programmer

Responsibilities:

• To analyze the Pre-Clinical and Clinical Study data on Oncology and CNS domain by using basic computer applications and statistical methods as; Excel, Assay Zap, SPSS including BASE/SAS and sound ability to summarize, interpret, report and presentation of the experimental data.
• Provided Clinical SAS/BASE Programming and Analysis support for Clinical Trials data.
• Experience with Clinical Study Methodologies, Clinical Trial Phase I - IV.
• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Serious Adverse Events, Vitals, Laboratory Data.
• Extracting data from DB2, SyBase and Oracle using SAS/Access, SAS/SQL and created SAS Datasets.
• Involved in validating code, debugging and reporting data on TFL format.
• Participated in different kinds of Statistical Predictive Modeling and Experienced in different biostatistical software including STATA and JMP.
• SAS Macros were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Generated tables and listings based on CDISC (SDTM and ADaM BDS) standard for FDA Submission.
• Experience in handling complex processes using different Environment; SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/ODS, SAS/IML, SAS/SQL and SAS/ACCESS.
• Performed duties sometimes as a QA and BA analyst as per project demands.
• As an Assay Development Scientist primarily focused on various Immunoassays mainly Cell Based Assays (primary and recombinant) and Biochemical Based Assays.
• Working on different Primary Cell Cultures including Mouse & Rat (Dorsal Root Ganglion) Neurons etc.
• To maintain the high standard of cGLP/GCP/GMP and CLIA as per FDA/ ICH guidelines.
• To write and edit the cGxP compliant document that needs to be, including SOP, Assay Validation Protocols, Training and Reports.

Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ODS, SQL Server, MS Excel, WINDOWS 2000, UNIX, Clin-Trial, Molecular & Cell biology technique

Confidential, PA

Research Fellow/ Scientist (SAS)

Responsibilities:

• Worked as a member of the Drug Discovery and Designing team on different compound molecules, Cell Based Assays and Biochemical Based Assays.
• Analyzed the data by using different applications and statistical tools as; Excel, Assay Zap, SPSS, SAS/BASE and timely report to the supervisor.
• Provided BASE/SAS Programming support for Pre-Clinical and Clinical Trials data.
• Prepared SAS Programs/Macros for safety tables, listings and graphs (TLG), occasionally for efficacy tables and validating data.
• Participated in design, review and QC of database structure of clinical studies.
• Involved in different kinds of Statistical Modeling and Experienced in different biostatistical software including SPSS and JMP.
• Performed other assigned duties as a QA and BA too.
• Duties includes testing wide range of pre-clinical and clinical samples (Serum, Plasma, Urine and Whole Blood) collected from different clinical trials study by ELISA, Virus Neutralization Assay, Cell Based Assays, and Flow-Cytometry.
• Worked in a different platform esp Metabolic, Cardio Vascular and Dermatology platform (Hypersensitivity and Acne) by wide variety of Immunoassays including Luminex Multiplex-High through put Screening, PK/PD and Enzyme kinetics study.
• Protein Conjugation, GPCR, rDNA cloning, qRTPCR, FPLC, LCMS/MS, GCMS/MS.
• Culturing and maintaining different types of recombinant human/ mammalian cell lines such as HeLa, HL-60, NALM-6, PC-3, VCaP, MCF-7, and primary cell culture.
• Writing SOP’s, trouble-shooting and conducting experiments based on cGLP/cGMP/cGCP under FDA & ICH guidelines.

Environment: SAS/BASE, SAS/MACROS, SAS/GRAPH, Clin-Trial, PL/SQL, Molecular & Cell biology technique

Confidential

Responsibilities:

• Prepared SAS programs/Macros for validating pre-clinical/clinical data and QC/QA.
• Isolation of protein extracts from mice tissue harvesting, homogenization of the mice tissues by tissuemizer, liver cell fractionation and assay of organelles fractionations.
• Protein extraction, purification and characterization by ELISA, SDS-PAGE, Western Blot, protein purification, IP/IC/IHC, Flow-Cytometry (FACS) for GFP analysis. rDNA Cloning, Site-Directed Mutagenesis, and making hGPR40/43 Chimeras, DNA-Fingerprinting, Vector Designing by Vector NTI software, Primer Designing, Ligation, Agarose Gel electrophoresis, Plasmid preparation.
• To perform apoptosis, cell/chromosome counting on different cell line as human cell line (HeLa) and other mammalian cell line too.
• Northern Blot, Transfection (Lipofection), and 2D gel electrophoresis, DNA/RNA/Plasmid isolation, PCR/ qPCR/RTPCR, RFLP/AFLP, GCMS/MS, and LCMS/MS.
• Bacterial Transformation/Transduction, Virus Neutralization Assay, & C-Nano-Tubules.
• Preparing different Biochemical and Microbiological media/reagents, Isolation, Enumeration and Characterization of Bacteria, Fungi, Virus, and Fermentation.
• Culturing and maintaining different cell lines as HeLa, HEK 293, LNCaP, CHO, KRIB, Jurkat, NIH 3T3 etc, grading quizzes and managing grade book of the students.

Environment: SAS/BASE, SAS/MACROS, SAS/GRAPH, Clin-Trial, PL/SQL, Molecular & Cell biology technique