Divya Srinivasan

acde0p@r.postjobfree.com

732-***-****

SUMMARY

. 6 plus years of experience in Pharmaceutical / CRO industry as Certified

SAS programmer and advance skills in Base SAS, SAS/SQL, SAS/Macros,

SAS/Graph, SAS/Stat and SAS/Connect in Windows and UNIX environments.

. Developed SAS Programs to produce and validate analysis datasets,

listings, graphs and summary tables of safety and efficacy data for Phase

I-III clinical trials.

. Strong working knowledge in clinical trial data analysis, generating

reports and summary tables, listings and graphs as per Statistical

Analysis Plan (SAP) and protocol specifications.

. Experienced in programming edit checks and patient profiles for Data

management teams.

. Experienced in analyzing the clinical trials and generating reports,

tables, listings and graphs for internal purpose and for FDA according to

the 21 CFR Part 11.

. Good understanding of CDISC SDTM models and experience in converting

legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.

. Experience in data mapping from none CDISC SDTM to SDTM and data mapping

from SDTM to ADaM standards.

. Experienced in creating non-standard ad-hoc requests as per statisticians

demand.

. Good understanding of complex SAS concepts like macros, SAS arrays and

Proc SQL.

. Experienced in working with graphs and annotating them using Proc gplot

extensively.

. Knowledge of generating electronic deliverables & submissions for

Integrated Summaries (ISE/ISS). Familiar with IND and NDA submissions,

Clinical Terminology and Regulatory Guidelines for FDA submissions.

. Generated several permanent outputs in RTF format per client's

requirement using SAS/ ODS and Proc report.

. Experienced on creating efficacy datasets and efficacy tables using

statistical procedures.

. Exceptional problem solving skills for delivering useful and prudent

solutions. A quick learner with an eye for detail and excellent

analytical and quantitative skills.

PROFESSIONAL EXPERIENCE:

Eisai Pharmaceuticals, Woodcliff Lake, NJ

Oct 2011 - Present

Sr. SAS Programmer

Therapeutic Areas: Oncology.

Responsibilities:

. Involved in the support of Phase II, and III clinical trials.

. Involved in creating specifications documents for SDTM and ADAM using

annotated CRFs, SAP, mock-shells and Implementation guide.

. Created several domains in CDISC i.e., both SDTM and ADAM datasets on

production side as well as validation side using specification.

. Good understanding of CDISC concepts and control terminology for SDTM

IG (3.1.1 and 3.1.2) and ADAM IG (1.0 and 2.0).

. Worked as both production programmer and validation programmer in the

process of creating Tables, Listings and Graphs.

. Worked in the team preparing Integrated Summaries of Efficacy (ISE)

and Safety (ISS) reports.

. Created edit-check program and created clinical review listing for

clinical team to review for data consistency.

. Created ad hoc programs to provide information to the project team

and/or client, as required.

. Imported data in the form of SAS datasets from flat files of various

formats like tab delimited, .CSV, .XPT etc.

. Developed Macros to generate ad hoc reports weekly, monthly or on a

specified cut date.

. Created various study specific macros by implementing debugging

options.

. Created data quality listings to ensure data correctness and clinical

review for clinical team.

Roche Pharmaceuticals, St Nutley, NJ

Jan 2009 - Aug 2011

Clinical SAS Programmer

Therapeutic Areas: CNS, Pain.

Responsibilities:

. Worked on Phase I, II and III Clinical Trials data for various

therapeutic areas.

. Worked on both CDISC and non-CDISC standard dataset as per client

requirement and need. Created specification for the dataset

programming.

. Created various analysis datasets from SDTM datasets and wrote some

study specific macro for derivation of analysis variables.

. Worked with macro development team for modifying existing macros and

creating new macros.

. Worked on very strict timeline provided by client and created output

with highest quality output as per client requirement.

. Performed Data analysis, generated Tables, listings and graphs as per

requirement and based on mock up shell.

. Extensively used SAS/ Macro facility to provide reusable programs that

can be conveniently used time to time and created tables, graphs and

listing reports.

. Participated in weekly meetings and weekly priorities meetings to

discuss the requirements and gather the client comments on the current

study and set programming priorities.

. Involved in developing Kaplan-Maier Survival curves for comparison of

event free survival rates using Proc Life test and Proc Gplot.

. Involved in preparing the necessary documents (metadata in define.xml,

datasets in .xpt format) required for regulatory submissions (NDA).

. Performed Validation and QC of datasets, tables, listing and graphs.

Omnicare Clinical Research, King of Prussia, PA

Apr 2008 - Nov 2008

Clinical SAS Programmer

Therapeutic Areas: Oncology

Responsibilities:

. Worked as a SAS Programmer on Phase II and III Clinical trials in

Oncology.

. Successfully designed and implemented statistical reporting processes

for regular data collection and clinical data analysis.

. Created various datasets like LB, AE, DM, VS from raw datasets from

various formats such as following the specifications.

. Performed program documentation on all programs, files and variables

for accurate historical record and for future reference.

. Created Analysis Datasets and derived new variable as per

specifications and need.

. Created various Listings, Tables and Graphs for Labs, Adverse Events,

PK/PD, Conmeds, Disposition, Vitals, and Demographics etc.

. Created PK Merge files and converted SAS Datasets into XPT and vice

versa.

. Worked as QC programmer and as well as a primary programmer for

datasets and TLG programming.

Quartesian CRO, Princeton, NJ

Jan 2007 - Mar 2008

SAS Programmer

Therapeutic Areas: Cardio-Vascular

Responsibilities:

. Worked in Phase I clinical trials for studies in the Cardio-Vascular

therapeutic area.

. Involved in writing the SAS codes to help in the process of quality

control by implementing various statistical procedures like Proc freq,

Proc means, Proc univariate and other procedures like Proc Summary,

Proc Transpose, Proc SQL and Proc print.

. Created SAS Macros and modified the existing ones relating to multiple

studies.

. Created, derived and merged and pooled datasets, listings and summary

tables for Phase-I clinical trials.

. Generated tables, listings and graphs using MACROS, PROC TABULATE,

PROC REPORT and PROC PRINT according to Statistical Analysis Plan.

Northwestern University, Chicago, IL May 2006 - Dec 2006

Research Data analyst.

Responsibilities:

. Extensively used SAS for mixed model analysis of DNA microarray data.

. Used SAS/genetics software for analyzing genetic marker data

. Used SAS procedures like Proc KDE and Proc CALIS to investigate gene

marker data.

. Used Proc KDE to find the population distribution of gene markers for

one treatment, or multiple treatments.

. Used Proc CALIS to develop structural equation models that can provide

a means to examine the relationships between gene markers.

Education:

. M.S., Biochemistry, University of Illinois, Urbana, IL

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