Sravanthi Gujjari

Phone: 612-***-****

Email: acciy4@r.postjobfree.com

SUM MARY:

• Over 6 plus years of experience in SAS programming with good knowledge of

advanced statistical methodologies applied in Pharmaceutical, Genetic and Biotech

i ndustries.

• Expertise in analyzing and reporting various phases (Phase I I-I I I) Of Clinical T rials

using tools like Base SAS, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS,

SAS/ODS in Windows environment.

• Experience in creating CDISC complaint SAS datasets (SDTM and ADaM) as well

as generating Tables, L istings and Figures.

• Experience in Data manipulation and producing reports employing various SAS

p rocedures like PROC SQL, PROC REPORT, PROC TABU LATE, PROC FREQ,

PROC MEANS, PROC UN IVARIATE, PROC SUMMARY, and PROC CONTENTS.

• Skilled in using the SAS/ODS facility to convert data to P DF, HTML and RTF

formats.

• Extensive exposure on every steps of entire project life cycle such as SAP, original

data collection, data query, data manipulation and analysis, summary of findings

and presentation of results.

• Having knowledge of clinical and pharmaceutical drug development process and

associated Good Clinical Practice (GCP).

• Extensively involved in creation and validation of analysis datasets, Tables, L istings

and Graphs (TLG) and Ad-hoc reports.

• Good understanding of Clinical Trial Phases, clinical protocols/ CRF’s/Annotated CRF’s, ICH and

GCP guidelines, NDA, IND, CDISC, MEDRA, 21 CFR PART 11. Familiar with Electronic

submission guidelines to FDA.

EDUCAT ION:

• Masters in Clinical Research from Institute of Clinical Research (ICRI) India.

• Post Graduate Diploma in Clinical Research Management at ICRI, India.

• Bachelor of Pharmacy from Jawaharlal Nehru Technical University (JNTU), India.

TECHN ICAL SKILLS:

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SAS Skills : SAS (Base, ACCESS, STAT, MACROS, ODS, SQL and GRAPH)

L anguages : SAS, SQL, Oracle Clinical

Databases : MS-ACCESS, Oracle Clinical

Environment : SAS 9.0, SAS 9.1.3, Base SAS, SAS macros, SAS/Access and

W indows

A dditional Software : MS Office Suite (Word, Excel, PowerPoint)

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PROFESSIONAL EXPER IENCE:

C linical SAS Programmer

Cook County Hospitals, Chicago, I L Jan 2013 – T i l l Date

Responsibilities:

• Successfully designed and implemented statistical reporting processes for regular data

collection and clinical data analysis for Phase I and I I I analysis of clinical t r ials.

• Performed validation of tables, listings and graphs for clinical study reports.

• Developed SAS programs for listings and tables for data review and presentation, including

ad-hoc reports, Case Report Tabulations as per CDISC guidelines.

• Involved in (ISS/ISE) integrated summary of safety and integrated summary of efficacy

analysis in creating the ISR (integrated summary report) to compare and to differentiate

a ll other study results and to get the conclusion after reviewing the patient benefit/risk

p rofile of the drug.

• Involved in creating the statistical analysis data sets according to the ADaM standards to

submit analysis data to FDA.

• Writing SAS programs as per the instructions provided by study Statisticians to create SAS

datasets, Tables, Listing and Figures reporting and submitting the results of clinical t r ials

for investigational medications.

• Develop the validation plan for the SDTM datasets for the submission and validate the

datasets by parallel programming.

• Programmed and generated safety tables, efficacy tables, patient profiles, demographic

l isting, vital signs and reason for withdrawal from the t reatment for FDA submissions.

• Involved in SDTM mapping, pooling and analysis of clinical study data for safety.

• Created Safety as well as Efficacy Reports for FDA submission.

• Involved in CRF (Case Report Form) annotations.

• Performed QC (Quality Check) extensively on tasks performed by other team members.

Clinical SAS Programmer

Dataceutics, Pottstown Jan 2010 – Dec 2012

Responsibilities:

• Provided SAS p rogramming and analysis support for Phase I I-I I I clinical t r ials.

• Lead the various client projects for generating SDTM-compliant datasets (wri ting specs,

mapping, programming and QC)

• Generated safety tables (Adverse Events, Patient profile, Demographic listing, Vital Signs,

Reason for withdrawal by t reatment).

• Generated high quality reports in the form of listing and RTF using SAS ODS.

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• Primary p rogrammer to produce tables, listings, and figures for the clinical study report

(CSR).

• Secondary p rogrammer to validate SAS p rograms that produce derived-analysis datasets

and data analyses.

• Worked closely with Study statisticians to implement the analysis specified in Statistical

A nalysis Plan (SAP).

• Used SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro to implement statistical analysis

p rocedures, generate reports and graphs.

Clinical SAS Programmer

Novartis healthcare Pvt. Ltd, Hyderabad, I ndia Aug 2007 – Sep 2009

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical

s tudies across multiple protocols for the submissions like NDA and Safety.

• Performed validation of tables, listings and graphs for clinical study reports.

• Involved in Developing, and validating the project-specific SAS programs to generate

derived SAS datasets, summary tables, and data listings according to departmental standards.

• Used Sorting and Merging techniques on the raw data sets for value added data

p reparation, to get the required Reports or Analysis data sets.

• Performed QC (Quality Check) extensively on tasks performed by other team members

and involved in data validation and data cleaning in all phases of Clinical studies.

• Extensively used Proc SQL to ret rieve, update and report on information from SAS data

sets and other database products.

• Buil t Macros and create macro variables using %LET, CALL SYMPUT, and DATA

_NULL_ to help generate analysis data sets and create specified structure of TLFs.

• Used Proc CDISC for verifying compliance of datasets with CDISC standards and electronic

submissions.

• Worked on multiple protocols and/or drug compounds at a time.

• Programmed and generated safety tables, efficacy tables, patient profiles, demographic

l isting, vital signs and reason for withdrawal from the t reatment for FDA submissions.

Clinical SAS programmer

Datamonitor, Hyderabad, I ndia June 2006 – July 2007

R esponsibilities:

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• Involved in the support of Phase I I and I I I clinical t r ials; Regulatory submissions;

• Worked on the safety (ISS) and efficacy (ISE) listings for the various studies

• Created and maintained SAS datasets that are extracted from Oracle C linical/Clint r ial

databases using SAS DATA STEP and PROC SQL.

• Conducted analysis on the raw data to determine the quality and validity of the data using

P roc Freq and Proc Means.

• Participated i n creating CDISC compliant datasets – w rit ing specs, mapping variables and

coding for t ransformation

• 1Generated RTF and PDF output using SAS/ODS.

• Responsible for developing the SAS p rograms following the information stated in Statistical

A nalysis Plan (SAP); Created derived datasets for analysis.

• Review of specifications, mock-up tables and listings

• Involved in validating and QC of the derived datasets, efficacy and safety tables.

• Created tables, listing, and graphs for Safety as well as Efficacy analysis for the Study

• Generated TABLES and L ISTINGS using Proc Freq, Proc Means, Proc Univariate, Proc

P rint, Proc Tabulate and Proc Report.

• Developed and updated existing MACRO programs.

• Contributed to the development of standard operating procedures (SOPs).

• Produced Ad-hoc reports as per requests.

PERSONAL DETA I LS:

Current Location: I ll inois

Work Permit: H1B

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