NikeshC

Phone: confidential

Email: ac4kpn@r.postjobfree.com

PROFESSIONAL SUMMARY

SAS/ Statistical programmer with over 8 years of experience in data management and statistical programming in various phases of clinical trials working for Pharmaceutical companies and Clinical Research Organizations (CRO).

An intensive experience in analyzing and reporting data for Phase I to Phase III Clinical trials.

Knowledge of Life Sciences with extensive experience in the clinical trial processes and their designs including open-labelled, single blinded, double blinded, randomized and crossover studies.

Worked in oncology, cardiovascular, Infectious disease, diabetes, dermatology therapeutic areas.

Excellent knowledge of the clinical trial process and 21 CFR part 11 and 50 in drug development in various therapeutic areas.

Proficient in importing or extracting data by connecting SAS System to database systems such as MicrosoftSQL, Oracle, Excel, flat files

Extensive work experience in creating CDISCSDTM (V 3.1.1, V3.1.2, V3.2) and ADaM (V 1.0) datasets.

Proficient in understanding clinical trials study designs, study protocols, statistical analysis plans, (SAP), case report form (CRF/eCRF), annotated case report forms and company Standard Operating Procedures (SOP).

Extensive experience in generating Analysis Datasets and in created specifications for CDISC SDTM, ADaMby using company standards

Experience in Dataset Creation and Table/Listings Programming for integrated Summaries of Efficacy (ISE) and Safety (ISS).

Hands on experience in handling clinical trial data such as demographic data (DM), adverse events (AE), laboratory data (LAB DATA), concomitant medications (CM), subject visits (SV) and vital signs (VS).

Utilized MedDRA and WHO-DRUG dictionaries in creating summary tables for Adverse Events and Concomitant medications respectively.

Experience in storing and managing SAS data files, merging, using Arrays, SAS Macros, SAS Formats and Informats.

Expertise in SAS/BASE, SAS/SQL, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS.

Familiar with PROC GLM, PROC GPLOT and Kaplan Meier Curve.

Knowledge in statistical analysis methods such as t-test, regression analysis, ANOVA along with analyzing p-value generated from various statistical procedure.

Good knowledge in developing various reports using data _null_, proc report and SAS ODS for developing desired formats such as .pdf, .rtf and other formats.

Developed numerous Ad Hoc reports as required by medical writers/regulatory authorities and FDA.

TOOLS AND TECHNOLOGIES

SAS Products

SAS 9.1.3, BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/REPORT, SAS/SQL, SAS/CONNECT

SAS Procedures

Print, Means, Univariate, Freq, Sort, Summary, Format, Transpose, Compare, Correlation, Regression, SQL, Tabulate, Import, Export

Databases

Oracle Clinical, MS Access.

Other Utilities

Microsoft Office (Excel, Word, Power point)

Operating systems

Windows XP/ 2000, UNIX, Windows 7

EXPERIENCE

Confidential Nov. 2015– Present

Senior SAS Programmer

Involved in Validation/QC of analysis datasets and generated tables, listings, and graphs.

Develop analysis datasets and generate tables, listings, and graphs as per SAP.

Wrote SAS listings and tables in PDF, RTF, using SAS ODS.

Developed and maintained routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions.

Prepared, processed and analyzed clinical data required for analysis of clinical trials with SAS programming.

Maintains documentation regarding project progress, validation and programming updates and all other documentation as required on a regular basis.

Reviewed 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.

Provide programming support in generating and\or validating analysis datasets (SDTM and ADaM).

Builds successful relationships and seamless interfaces at the protocol/project team level.

Involved in Validating ISS/ISE Tables and Reporting.

Involved in creating Transport-files for electronic submissions to FDA.

Used DATA _NULL_ technique for reporting outputs. Produced quality customized reports using TABULATE, REPORT and SUMMARY procedures and provided statistics using procedures for MEANS, FREQ and UNIVARIATE analysis.

Contributed to Case Study Reports (CSR) and documents to be submitted to FDA.

Confidential Oct’2013 – Oct’2015 Dec 2009. – Nov. 2011

Senior SAS Programmer

Used SAS to analyze data, statistical tables, produce listings and graphs for reports

Wrote SAS code using SAS/BASE and SAS/MACROS to import data from external data files, such as Excel, Access, and Oracle.

Extracted data from flat files, MS Excel and Oracle Clinical database and created SAS data sets using different SAS procedures and SAS/SQL.

Developed, modified, validated and implemented SAS programming work according to Statistical Analysis Plan (SAP).

Worked in Cardiovascular, Infectious disease therapeutic areas.

Conducted and generated the Regression, Correlation studies and Analysis of Variance using PROC REG, PROC CORR, PROC GLM, PROC ANOVA.

Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).

Created SDTM domains from raw datasets as per CDISC standards.

Created analysis datasets(ADaM) from the SDTM domains and generated TLGs.

Interact with other departments such as Clinical Operations, Project Management, and Data management to ensure a high level of client satisfaction through successful execution of projects.

Participate in review process of study documents such as CRF, edit check specifications, and database design specifications written by Data Management.

Reviewed data from clinical trials and developed plans to presenting results to FDA

Confidential Jul’2011 –Oct’2013 Jan. 2007 - Dec. 2009

Senior SAS Programmer

Served as primary SAS programmer and collaborate with statistician in analyzing initial data sets and generating tables, listings and figures (TLFs) for clinical trials

Wrote code using SAS/Base and SAS/Macros to extract clean and validate data from Oracle clinical.

Involved in the support of Phase I, II, and III clinical trials for Cardiovascular and Oncology therapeutic areas.

Developed specifications for database in CDISCSDTM and ADaM format and involved in programming datasets in CDISC format (STDM model 3.1.2, 3.2) and managed CDISC for several studies.

Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS/Tools, SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access

Created macros in SAS to extract and transform data to SAS datasets from different sources and developed SAS programs for data cleaning, validation of the data as per the Data Management Plan.

Produced quality customized reports by using TABULATE, REPORT, and SUMMARY and provided descriptive statistics using MEANS, FREQ, and UNIVARIATE.

Involved in writing and updating the project level macros for data management support programming.

Integrated SAS datasets into Excel using Direct Data Exchange, using SAS to analyze data, statistical tables, listings and graphs for reports

Extensively used PROC LIFETEST to predict and study the timing of events, efficacy endpoints of clinical trials.

Formatted RTF PDF and HTML reports, using SAS - output delivery system ODS

Confidential Mar’2009 – Jun’2011 Jan. 2004 – Dec. 2006

SAS Programmer

Collected and entered raw data into the system using MS Access and MS Excel using various import wizards.

Data step programming with SAS functions mainly INPUT, PUT, SUBSTR, INDEX, SCAN, COMPRESS, CATX

Performed statistical data analysis using various SAS procedures such as PROC SORT, PROC FREQ, PROC SUMMARY, PROC PRINT, PROC MEANS, etc.

Created Mock Tables mentioned in the Statistical Analysis Plan.

Worked in Analysis data sets, Tables, Listings and Figures.

Assisted in data cleaning and validation. Tested and debugged macros.

Generated Analysis data sets, Listings, Tables and Graphs using PROC MEANS, TABULATE, REPORT and SAS/GRAPH.

Acquired knowledge in Clinical Trial terminology, Good understanding of Clinical Trial Phases, clinical protocols/ CRF's/Annotated CRF's, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11.

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