SUMMARY

. Certified SAS programmer with * years of experience in data analysis

and reporting in all phases of clinical trials.

. Strong knowledge involving all phases (I-IV) of clinical trials.

. Worked on SAS/Base, SAS/Stat, SAS/Graphs, SAS/SQL and SAS/Macros.

. Worked in mapping CRF variables to SDTM and SDTM to ADaM standards.

. Wrote specifications for SDTM and ADaM datasets.

. Strong knowledge on writing SAS data step programs and creating

different SDTM and Adam datasets.

. Expertise in analyzing and coordinating clinical trial data,

generating reports, tables, listings and graphs.

. Performed QC of datasets and TLG using parallel programming, output

and code review.

. Generated Integrated Summary of Safety (ISS) reports.

. SAS programming experience in UNIX and windows environment.

. Good experience with biostatistician and data management team.

. Strong ability to quickly adapt to new applications and platforms.

. Good team leader with strong analytical and communication skills.

. SAS Certified Base and Advance SAS Programmer.

PROFESSIONAL EXPERIENCE

Parexel International LTD, NC

Jan 2014 to till date

Sr. Statistical SAS Programmer

. Involved in Phase II and III clinical trials by providing required

SDTM+ dataset, Tables and Listing.

. Developed Supplement datasets by using CDISC standers.

. Generated population flags and derived flag in SDTM datasets.

. Involved in mapping raw data and write data specification documents.

. Created study level macro to derive EPOCH, TAETORD, STDYRELP, AEDOSDUR,ETCD etc.

. Involved in Validation process for datasets by using Proc Compare.

. Created datasets, tables and listing by using SAP and Mock shell.

. Worked on various OS such as UNIX and WINDOWS to perform and execute

datasets, tables and listing.

. Performed various tasks at multiple studies during Clinical trial

phase.

. Worked closely with data management team to resolve data issue.

Medimmune, Gaithersburg, MD

Sr. Statistical SAS Programmer

Feb 2012 to Jan 2014

Created SAS programs to generate SDTM and ADaM datasets as per CDISC

standards.

Created Data Definition Specification (DDS) for SDTM and ADaM

datasets and or wrote SAS program accordingly.

Developed Standard and study level Macros to create tables, graphs

and listings for inclusion in clinical study reports.

Generated Safety and Efficacy Table Listing and Figures (TLF) as per

Statistical Plan (SAP) and Mock Shells.

Used Output Delivery System (ODS) to produce RTF, PDF, HTML and

EXCEL outputs.

Analysis Generated ISS and ISE for submissions to NDA.

Involved in programming and validation for generation of tables

safety and efficacy analysis.

Involved in checking data is as per SDTM standards.

Worked for performing the Adhoc analysis per regulatory request.

Worked closely with Statisticians and Data management team.

Extensive experience in working with people across other sites when

required.

Participated in Weekly Meeting with Team Lead, Co-workers to discuss

about the work progress and queries regarding Project.

Medimmune, Gaithersburg, MD.

April 2009 to Jan 2012

Sr. Statistical SAS Programmer

Mapped raw data variables and defined specifications for derived

datasets.

Created analysis dataset to enable statistical analysis as described

in SAP.

Involved in programming for Integrated Summary of Safety (ISS).

Created transport files (.XPT files) for FDA submission.

Consulted Biostatistician and Data Management group for smooth

operation of

Derived analysis datasets and produced tables, listing and graphs as

per the SAP.

Helped mapping the raw data variables and writing specifications for

derived datasets.

Involved in writing macros for reporting and coding of complex data

analysis logic.

EDUCATION & PROFESSIONAL DEVELOPMENT

. Bachelors of Science, Microbiology, SP University, 2008.

. Certification: Base & Advance SAS certified.

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