SURESH BASIREDDY

201-***-****

adeiia@r.postjobfree.com

*** ********* **

Secaucus, NJ 07094

PROFESSIONAL SUMMARY

Education:

Master of Science in Civil and Environmental Engineering, Aug 94

University of Rhode Island.

Bachelor of Science in Civil Engineering, Jun 91

Osmania University.

PROFESSIONAL EXPERIENCE:

NYU Langone Medical Center, New York, NY

Senior SAS Programmer July 2017 to Mar 2019

* Worked on the Oncology studies.

* Reviewed Protocols, Mapping Document, and Statistical Analysis plan.

* Programmed analysis datasets in SAS according to specifications.

* Produced tables and listings required for various studies.

* Worked on the tumor, radio therapy, drug treatment, and safety tables for safety and efficacy

analysis.

* Used the Standard Macros, Proc Report, Proc Print, Proc SQL, and various SAS Statements

and Functions to program the analysis datasets, tables and listings.

* Used windows 10. operating system for SAS 9.4 Software.

Eliassen Group Inc., Somerset, NJ

Senior SAS Programmer Jun 2015 to Sep 2016

* Worked on the Hemophilia studies (Refacto drug) and Acromegaly studies (Somavert drug).

* Worked on the ADAM AE tables for the ISS.

* Reviewed Protocols, Mapping Document, and Statistical Analysis plan.

* Programmed analysis datasets in SAS according to specifications.

* Produced tables and listings required for various studies and for ISS.

* Perfomed qc for analysis datasets, tables, listing and graphs.

* Developed the tables, listings and analysis datasets in the CDARS.

* Worked on the efficacy, safety and ISS analysis.

* Used the Standard Macros, Proc Report, Proc Print, Proc SQL, Data _Null_, various SAS Statements,

and Functions to program the analysis datasets, tables and listings.

* Used Liunix operating system for SAS 9.2 software.

Pharmaceutical Research Associates Inc., Blue Bell, PA

Clinical Programmer II October 2013 to June 2015

(Senior SAS Programmer)

* Worked on the Musculoskeletal repair studies and Gvhd studies.

* Wrote specifications required for conversion from the raw datasets to SDTM Domains.

* Programmed analysis datasets in SAS according to specifications.

* Programmed statistical analyses (e.g., TLFs, inferential statistical output according to the statistical

analysis plan or other specified requirements using SAS ).

* Worked on ADAM demog and ADSL tables, and SDTM safety tables for oncology study.

* Produced the statistical tables using Proc mixed, Proc Freq (fisher exact), and Proc npair1way

* Worked on the efficacy, safety and ISS analysis.

* Produced bar plots, and line plots for Efficacy analysis.

* Performed quality review of SAS programs generated by other SAS programmers and

biostatisticians.

* Provided additional SAS programming support as requested.

IPSEN Biopharmaceuticals Inc., Basking ridge, NJ Mar 13-Jun 13

SAS Programming Consultant

* Worked on acromegaly registry study.

* Develop Analysis datasets and tables required for study eligibility, informed consent, demographics,

medical history, acromegaly history, serum GH level after OGTT, serum IGF-1 level, drug

administration, adverse events, physical examination, vital signs, specialty tests, convenience

questionnaires and concomitant medication assessments.

* Used proc print, proc report, proc means, proc glm procedures, various SAS statements and ODS

facility for producing analysis datasets, tables, and listings.

Eisai Inc, Wood Cliff Lake, NJ Apr 12 – Dec 12

SAS Programming Consultant

* Reviewed CRT datasets against the bank CRF pages for all pages in the CRF book.

* SDTM variables were annotated on the PDF blank CRF for special purpose datasets, intervention

datasets, findings datasets and supplemental qualifiers datasets of hepatic oncology studies and renal

impairment oncology studies.

*Wrote specifications on the excel spread sheet to map variables from CRT datasets to SDTM datasets

such as special purpose datasets, findings datasets, intervention datasets and supplemental qualifiers

datasets using SDTM Mapping specifications for hepatic oncology studies and renal impairment

oncology studies.

Pfizer Inc, Cambridge, MA May 10-Sep 11

Statistical Programming Consultant

*Worked in the oncology and anti-Inflammatory therapeutic areas.

* Assigned the programming task to junior programmers, mentored the junior programmer, attended the

meetings and interacted with SAS programming, data management, biostatistics and medical affairs

departments.

*Reviewed SAP, analysis dataset specifications and protocols. Developed and validated analysis datasets

required for efficacy and safety analysis. Produced and checked safety and efficacy tables, listings and

graphs.

*Produced graphs using Gplot, proc greplay and the annotate dataset. The standard macros, many SAS

procedures such as proc report, proc print, proc sql, proc lifetest, various SAS statements and functions

are used to program the analysis datasets, tables and listings.

Averion International Inc, South Borough, MA Sep 08-Nov 09

Senior Statistical Programmer

* Assigned the programming task to junior programmers, mentored the junior programmer, validated

junior programmers code, maintained validation tracking sheet, attended meetings and interacted with

SAS programming data management, biostatistics and medical affairs departments.

*Reviewed and provided comments required for the SAP, Analysis dataset specifications and Protocols.

Created derived datasets using CDISC(SDTM) and Created derived datasets without using CDISC.

Generate and verified Safety and Efficacy tables, listings and graphs required for oncology, anti-infective

and Pain/anti-inflammation Therapeutic Areas.

* Created Graphs using Proc Gplot. The Standard Macros, Proc Report, Proc Print, Proc SQL, various

SAS Statements, and Functions are used to program the analysis datasets, tables and listings.

Abt Bio Pharma Solutions Inc, Lexington, MA May 08-Aug 08

Statistical Programming Consultant

* Created safety tables and graphs, reviewed SAP and Protocol required for Breast Cancer Study.

* Created Graphs using Proc Gplot. The Standard Macros, Proc Report, Proc Print, Proc SQL, Data

_Null_, various SAS Statements, and Functions are used to program the analysis datasets, tables and

listings.

Eisai Medical Research Inc, Ridgefield Park, NJ

Principal Statistical Programmer/Analyst May 05- Dec 05

* Created some tables and validated other programmer’s tables and listings for E5564-A001-201(Anti

Infective) Study. Weekly meetings has been attended, reviewed SAP, and protocol and provided

comments. Errors in the database had been checked while working on tables. Junior programmers who

needed my guidance was helped, mentored junior programmers and maintained the leadership role.

Interact with various functions in the company.

Senior Statistical Programmer/Analyst Sep 02-May 05

* Got acquainted with the Eisai system and understood the existing programs and global macros.

Created new macros which are used across studies. Assisted new hires in learning SAS/UNIX.

* Reviewed and provided comments on protocol and statistical analysis plan to the statistician, created

randomization dataset, and worked closely with the clinical for the review of the tables and data listings,

coordinated electronic data transfer from CRO and Eisai Inc, UK for E2051-A044-001 study.

* Coordinated electronic data transfers form/to central labs/CRO to/from Eisai Inc., performed QC

and query generation of electronic lab data, and managed coding of adverse events and concomitant

medications for sepsis study.

*Worked with Statistician in creating standards for labs, non study medications, demographics, and study

termination analysis datasets and Working on the standards for AE analysis dataset for study E7389

-A001-101 and E7389-A001-102.

*Created SAS programs for analysis tables, and listings E2051-A044-001 (CNS), E7070 A001-106

(Oncology), and E7389 A001-101 (Oncology) studies. Write the edit check program for the edit specs

which are not covered by data management.

*Presented the SAS Programming directory structure to the SAS/Statistical Programmers and Statisticians.

Got the feed back from the group and worked for the final SAS programming directory structure.

Prepared the documentation required for the SAS Programming directory structure.

*Study E2051-A044-001: Broke the blind code, checked the treatment assignment and created the

randomization dataset.

* Participated in the monthly meeting of E7389-A001-101, E7389-A001-102, E7070-A001-106 and

E2051-A044-001 studies. Kept the team informed of the progress of programming and data issues.

* Produced adhoc tables for E7070-A001-106 annual report requested by regulatory.

*Adapted existing macros. Created the following macros:

Contents: To print the contents of all the tables in the database.

Print: To print data of all the tables in the database. For the particular number of observation, Please specify

number of observations in the macro. Other wise it will print data of the all tables in the database.

Study format: This macro convert the study code list from the oracle database to sas formats and stores the

formats in the study format directory.

Data format: The macro converts oracle table to SAS dataset and add the associated formats and labels to

the SAS dataset. The associated formats and labels are obtained from the Meta data table.

* Coordinated and checked the lab data obtained from the doctors laboratory for study E2051-A044-001.

Clarified the data issues with the doctor’s laboratory. Coordinated and checked the ECG data obtained

from the EISAI Inc London and Created ECG analysis dataset for E2051-A044-001 study. The ECG

analysis dataset contains unique record for each time point.

* Study E2051-A044-001: Created adverse event SAS analysis dataset using media dictionary. Sent the

term which is not coded automatically to the data management. Created nonstudy medication SAS

analysis dataset by merging with the dictionary. Obtained approval for non-study medication terms from

the study directory.

Courses:

Internal: Effective Communciation, Respecting Diversity, and Preventing Harassment.

External: SAS Macro Programming: Advanced Topics, Getting Started with the Output Delivery System

and Advanced Output Delivery System Topics.

Forest Laboratories Inc, New York, NY Dec 00-July 02

Statistical/SAS Programmer/Analyst

Operating System: Unix

* Worked on the Phase III Clinical Trials Safety analysis programming in the Psychiatry and Central

Nervous System therapeutic areas.

* Reviewed Protocols, Mapping Document, and Statistical Analysis plan. Created and validated various

analysis datasets of various studies. Mapped variables from the various studies analysis datasets

toIntegrated Summary Safety (ISS) analysis datasets variables.

* Produced tables and listings required for various studies and for ISS. Created UNIX script file using SAS

Software to compare previous version tables with the latest version tables.

* Validated others analysis datasets, tables, and listings of various studies and ISS.

* Used Proc Compare to compare the previous version and latest version datasets.

* Created the dataset and format catalog transport files required for NDA submission using Proc Copy and

Proc Cport.

* Programmed Statistics using Proc Univariate, Proc GLM, Proc ANOVA, Proc Means, Proc PHreg and

Proc Freq.

* Did Survival Analysis and Kaplan Meier Estimates using Proc Life Test.

* Created Graphs using Proc Gchart, Proc Gplot, Annotated datasets, and Proc Greplay.

* Used the Standard Macros, Proc Report, Proc Print, Proc SQL, Data _Null_, various SAS Statements, and

Functions to program the analysis datasets, tables and listings.

Pfizer Inc, New York, NY Sep 99- Nov 00

SAS Programmer/Analyst

Operating Systems: WIN NT and Unix

* Created the datasets for the Annual report using various SAS statements as per physical model for

Adverse Event, Demog, Lab, Testdrug, and Summary for various studies of various drugs in the anti

- infection therapeutic area of Phase IV clinical trials.

* Validated and cross checked the safety tables obtain from Clinical Research Organizations

for various studies of various drugs in the anti-infection therapeutic area of Phase IV clinical trials.

* Modified others tables and listings required for the safety and efficacy analysis.

* Statistics were programmed using Proc Freq, Proc Mean, Proc GLM, and Proc Univariate.

* The reports and listings were generated using Proc Tabulate, Proc Report, Proc Means, Proc Freq, Proc

Univariate, Proc Print, Data _Null_, Macro statements, Macro functions, and Standard Macros.

* Generated the safety reports using CDARS system.

* Programmed edit checks and ran edit checks using discrepancy management system.

Pharmaceuticals Research Associate, Shrewsbury, NJ May 99 - Sep 99

SAS Programmer/Analyst

Operating System: VAX/VMS, WIN NT.

* Migrated SAS data and SAS programs of all Protocol Studies from the Win NT Operating System to the

VAX/VMS Operating System using proc Cimport, proc Cport, Proc Copy, and using SAS Statements and

Functions. That includes Macro statements and Functions.

* Created analysis datasets, Generated Listings, Tables, Statistics and Graphs required for the Phase III and

Phase IV clinical trial Studies.

* The reports and listings were generated using Proc Tabulate, Proc Report, Proc Print, Data _Null_, and

Standard Macros.

* The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc Life test and Proc

Univariate.

* The graphs were created using Proc Gplot, Proc Gchart, and Annotated datasets.

* Used macro statements and macro functions.

* Converted Excel files to SAS dataset using Proc Access.

Astra Pharmaceuticals Company, Westborough, MA Dec 98 –May 99

SAS Programmer/Analyst

Operating Systems: HP UNIX, AT& T Unix, and Win NT.

* Migrated SAS data and SAS programs of all studies from the Win NT Operating System to the Unix

Operating System and Validated.

* The data being migrated using proc Cimport, proc Cport, Proc Copy, and using SAS Statements and

Functions. That includes Macro statements and Functions.

* Generated the exported SAS Listings and the exported SAS Tables on the Unix Operating System,

Printed, Documented and Validated randomly with the same Listings and the same Tables on the Win NT

Operating System.

* Created analysis datasets, Generated Listings, Tables, Statistics and Graphs required for the Pulmicort

Turbuhaler Phase III and Phase IV Studies.

* The reports and listings were generated using Proc Tabulate, Proc Report, Proc Print, Data _Null_ Macro

statements, Macro functions, and Standard Macros.

* The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc Life Test and Proc

Univariate.

* The graphs were Created using Proc Gplot, Proc Gchart, Annotated datasets, macro statements and macro

functions.

Novartis Pharmaceutical Company, E. Hanover, NJ Jul 96 – Nov 98

SAS Programmer/Analyst

Operating Systems: Windows, VAX/VMS and VM/CMS

* Created the data sets with flags, calculated various statistics and generated the reports, the listings and the

graphs required for ISS of Lamsil Solution (Nail Fungi) Phase III Studies.

* Generated the efficacy and safety reports, listings and graphs required for Sand immune Drug (RA

Symptoms) Phase III Studies and various clinical pharmacology studies.

* The reports and listings were generated using Proc Tabulate, Proc Report, Data _Null_ Proc Print, Proc

SQL, Macro Statements and Functions.

* The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc ANOVA and Proc

Univariate.

* The Graphs were created using Proc Gplot, Proc Gchart, Annotated Data sets and Macro Statement and

Functions. The analysis data sets were created using various SAS Language Statements and functions.

* Data transfer for Chib studies checked and validated the listings, reports and derived data sets generated

by Pharmaco.

SmithKline Beecham Pharmaceutical Company, Collegeville, PA Jul 95 - Jun 96

SAS Programmer/Analyst

Operating System: VAX/VMS

* Responsible for data pooling, creating data sets and generating reports for an Anti-Hypersensitive Drug

Study Protocols using Proc Tabulate, Proc Report, Data _Null_, SAS Arrays, Proc SQL and Macros.

* Converted oracle data to SAS data, created SAS access descriptor files, and SAS view descriptor files

using SAS/ACCESS.

Searle Pharmaceutical Company, Skokie, IL Jan 95 - Jun 95

SAS Programmer/Analyst

Operating System: HP-UNIX

* Pooled, cleaned and validated Concurrent Med Data, Physical Data, Acct Data, and Dosing Data of

various Arthrotec Studies using macros and various SAS statements.

* Created custom reports on Daypro Drug using Data _Null_, Arrays, SQL and Macros.

Boehringer Ingelheim Pharmaceutical Company, Danbury, CT Sep 94 - Dec 94

SAS Programmer/Analyst

Operating Systems: VM/CMS and OS2/Windows

* Used Data _Null_, SAS Arrays, SQL, and MACROS.

* Created custom reports on several types of data, including adverse event, concomitant medication, ECG,

treatment evaluation, patient record, index and scale data.

* Responsible for data reports for control of Perennial Rhinitis Symptoms of Parkinson Disease clinical

trial (Permpexole Tablet) and of Atrovent Clinical Trial (Nasal Spray).

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