Data Manager

SWETA DHARIA [pic]

* ****** **, *********, ** ***40, Contact: 908-***-****, Email:

********@*****.***

[pic]

SUMMARY

1. SAS Institute Certified Programmer with over eight years of experience

providing SAS solutions for Pharmaceutical and Biotechnology clients in

various high data environments.

2. Experience in analysis, design, development, UAT and implementation of

data in clinical trial projects.

. Expert hands on knowledge of SAS products (BASE, SQL, MACRO, STAT, GRAPH,

ACCESS, ODS) in UNIX and Windows environments.

. Extensive programming experience with SAS/BASE procedures such as Proc

(SQL, Report, Tabulate, Plot, Chart, Datasets, Format, Transpose, Print,

Contents, Append), SAS/STAT procedures namely Proc (Corr, Reg, Glm,

Anova, Freq, Means, Univariate), Proc (Gchart, Gplot) and Proc (Dbload,

Access) of SAS/GRAPH and SAS/ACCESS procedures, respectively.

3. Worked in all the phases of clinical trials, performed clinical data

analysis and generated SAS datasets, reports, tables, listings, summaries

and graphs in accordance with the Standard Operating Procedures (SOPs)

and departmental guidelines.

. Knowledge and understanding of 21 Code of Federal Regulations (21 CFR)

Part 11, FDA and other regulatory guidelines.

4. Experience in developing SAS procedures, macros, and applications for

data updates, data cleansing, and reporting for IND and NDA submission

for FDA approval.

. Performed data extraction from various databases like Oracle, Oracle

Clinical, SQL and MS Access. Experience in RDBMS - development using SQL,

PL/SQL programs in ORACLE.

. In depth knowledge of Clinical Trial data like Demographic data, Adverse

Events (AE), Serious Adverse Events (SAE), Laboratory data, Physical and

Vital Signs.

. Adept in identifying and implementing strategic solutions for business

problems.

5. Excellent leadership, analytical and problem solving skills and

interpersonal skills.

6. Quick learner and can adapt to rapidly changing environments.

TECHNICAL SKILLS

Statistical Software: SAS V6, V8, V9 (BASE, SQL, MACRO, STAT, GRAPH,

ACCESS, CONNECT, ODS).

Languages: PL/SQL, C, C++, Java, Perl.

Databases: Oracle 8i/9i, Oracle Clinical, SQL Server, MS-Access

2000/98, DB2.

Web Tools: HTML, Java Script, Front Page, XML.

Operating Systems: Windows XP/2000/98/NT, UNIX, MS-DOS.

PROFESSIONAL EXPERIENCE

ELI LILLY AND COMPANY, IN

Sept 08 - Present

Sr. SAS Programmer Analyst

Technical Skills: SAS 9, SAS/Base, SAS/Macro, SAS/SQL, SAS/STAT, SAS/GRAPH,

Oracle

Clinical, PL/SQL, SDD, MS-Excel, Windows NT and UNIX

Lilly is among the industry's leaders in investing in research and

development Lilly's internal research efforts focuses primarily on four

core therapeutic areas: neuroscience, endocrine disorders, cancer, and

cardiovascular diseases. As a Sr. SAS Programmer, I develop graphs and

tables required for pharmacogenomics and clinical trial analysis.

Responsibilities:

7. Lead assignments and mentor programming personnels on various projects.

8. Lead Pharmacogenomics (PGx) team and conduct biweekly team meetings to

enhance growth of PGx.

9.

10. Participating in Big Picture Leadership program.

11. Created SDTM datasets and well versed with SDTM implementation guide

version 3.1.1 and ISO 8601 date time CDISC standards.

12. Created ISS and ISE reports.

13. Created Integration Databases apart from PGx datasets and TFL's.

14. Ensures compliance to Standard Operating Procedures (SOPs), policies,

and guidelines.

15. Establish and implement programming standards and comply with

regulatory requirements among project team members and across all

studies.

16. Develop standard macros and/or tools in SAS for data analysis and

reporting primarily in Phase III and IV Clinical trials.

17. Create extensive graphics using SAS graph procedures to examine

relationship of primary and secondary safety or efficacy endpoints to

choose a suitable repeated measure mixed model.

18. Create analysis datasets, tables, listing, graphs, perform validation

and work with integrated databases.

19. Communicate to management on project status and resource issues.

20. Contribute to performance reviews of senior statistical programmers.

21. Being a member of I3 quality council, lead assessment on programming

SOP's.

GENENTECH INC., CA Apr 06 - July 08

Lead QC Programmer Analyst

Technical Skills: SAS 8, SAS 9, SAS/Base, SAS/Macro, SAS/SQL, SAS/STAT,

SAS/GRAPH, Oracle

Clinical, PL/SQL, MS-Excel, Windows NT and UNIX

Genentech is one of the most admired companies in the biotechnology and

pharmaceutical industries. Genentech currently focuses their efforts on

three disease category: Oncology, Immunology and Tissue Growth and Repair.

As a Lead QC Programmer, I verify the SPA developers' code and ensure

efficiency of code. I program and validated analysis datasets, tables,

listings and graphs for creation of CSR deliverables.

Responsibilities:

. Responsible for leading QC activities in support of SPAs and

studies(Oncology and Immunology related)

that are under a single SPA manager.

. Coordinates all study related QC communication and interaction with

that SPA

manager's team.

. Responsible for gathering and disseminating study specifications and

dependencies,

performing independent QC and completing related deliverables within

the required timeline.

. Use QC Plan and Merlin to ensure timely completion of QC tasks.

. Perform QC on all Phase I, II and III studies and resolve discrepancies

with SPA developers.

. Validate TLG's for FDA regulation.

. Extensively use Proc Report to tidy up the output for a clean comparison

of tables and listings.

. Verify TLG's and analysis datasets with respect to structured guidelines

and SOP.

. Provide feedback by making data presentations on QC process effectiveness

and performance.

PFIZER GLOBAL RESEARCH AND DEVELOPMENT, MI Jan 04 - Mar 06

SAS Programmer Analyst

Technical Skills: SAS 8, SAS/Base, SAS/Macro, SAS/SQL, SAS/STAT, Oracle

Clinical, PL/SQL, MS-

Excel, Windows NT and UNIX

Pfizer is one of the largest research based pharmaceutical company and has

produced innovative breakthroughs in a wide range of research areas,

including depression, erectile dysfunction, high cholesterol, HIV

infection, hypertension, bacterial infections and systemic fungal

infections. As a SAS programmer, I was involved in mapping the legacy

datasets acquired during Pfizer mergers to Pfizer standard datasets,

creating PK/PD datasets and generating TLG's for ADPlanner Code Conversion

project.

Responsibilities:

. Responsible for creating logical data maps required to initiate the

mapping of source data standards to Pfizer's PDS standard.

. Developed and implemented reusable programs and macros to create PDS

portal/SCRF datasets.

. Developed utility macros to assist in the Quality Analysis Checks which

includes record count comparison, review of WHO-Drug/MedDRA dictionary

coded terms, PDS code list check, core treatment check, truncation check,

left alignment check and attribute check.

. Peer reviewed the DCD's, code and execution of test plan in accordance

with the SDLC process.

. Downloaded safety and efficacy datasets from Oracle clinical database

using Proc Download and SAS WEB TOOLS and converted Oracle stable views

into SAS datasets.

. Developed and supervised implementation of programming standards and

conventions.

. Compared the legacy data presentations to the mapped PDS CDARS- generated

data presentations and annotated on both the data presentations as a part

of Quality check process.

. Documented the data mapping process for future reference.

. Responsible for creating PK/PD analysis datasets.

. Performed statistical analysis, generated reports, listings and for

ADPlanner Code Conversion project and have developed and implemented

reusable programs and macros.

. Performed integrity checks and wrote edit check programs for data

cleaning using SAS Macros and data step.

Wyeth, PA

July 02 - Dec 03

SAS Programmer - Clinical Research

Technical Skills: BASE SAS, SAS/MACRO, SAS/GRAPH, SAS/STAT, SAS/ACCESS, MS

Excel,

Oracle, Windows NT and UNIX

Wyeth Pharmaceuticals is one of the reputed pharmaceutical companies

conducting research on various medical disorders and involved in various

phases. It has conducted numerous studies on improving the outcome of the

patients well being. I worked on leading edge projects, with prime focus on

the development, management and implementation of using latest SAS

technologies.

Responsibilities:

. Conducted SAS data-step programming with data set creation and

manipulations.

. Developed SAS programs to support clean file management. Extracted data

from various repositories.

. Applied best programming practices to validate and clean the data to make

it fit for statistical analysis.

. Converted MS-Word documents and Excel tables into SAS data sets.

. Retrieved clinical data tables from ORACLE using Proc SQL 'Pass Through

Facility'.

. Queried, created, combined and modified SAS data sets using Proc SQL.

Generated the derived data sets for statistical analysis according to

SAP.

. Used sorting and merging techniques on the input data sets and used Proc

Transpose for Data manipulation, to get the required output and then

writing the code using SAS tools.

. Developed, maintained and utilized standard SAS naming conventions for

macro library supporting consistency and reusability of programs.

. Performed Statistical analysis of data using procedures, namely, Proc

(Report, Freq, Summary, Means, Univariate, Reg, and Corr).

. Created clinical data tables like Demographic summary tables, Adverse

Effects (AE), Serious Adverse Effects (SAE) tables extracted from ORACLE

and generated reports using Proc (Report, Tabulate) and Data _NULL_ (File

- Put) statements.

. Responsible for performing analysis of clinical trial data including

listings, tabulations, graphical summaries, and formal statistical

estimates and tests.

. Supported new drug development projects and contributed to project

documentation.

. Assisted in the review of clinical trial data capture processes and

media, including electronic data capture methods and paper CRF's. Ensured

that all data was collected in consistent formats to applicable

standards.

. Implemented standard and custom data listing, summary programs, graphs,

and statistical figures for inclusion in NDA.

. Assisted in developing report table specifications, validation and

verification of generated reports in compliance with FDA regulations and

policies.

. Developed SAS programs using ODS to produce HTML reports and Output data

sets.

CADILA PHARMACEUTICALS, INDIA Feb 01

- July 02

SAS Clinical Trials Programmer

Technical Skills: SAS/BASE, SAS/MACROS, ODS, SAS/SQL, SAS/ACCESS, Oracle 8,

UNIX and

Windows NT

CADILA Pharmaceuticals is a family of companies developing new drugs for

the improvement of the patients. I was involved in double blind placebo

controlled clinical trial studies for Phase II and Phase III.

Responsibilities:

. Responsible for performing the programming functions necessary to support

clinical research and clinical data management activities in

collaboration with the clinical data analysts within the group.

. Wrote, tested, and maintained programs used for review of data collected

during clinical trials.

. Created and extracted clinical data tables from Oracle to SAS using SAS

tools, SAS/SQL and SQL 'Pass Through Facility'.

. Involved in clinical data analysis and quality control to review the

discrepancies and resolved them by comparing with hard copies of the

CRF's.

. Extensively used SAS Macros in analysis of standard clinical data and

generated reports, graphs, listings, summaries and tables.

. Created accompanying PDF documentation for annotated CRF's and the data

definition tables with table of contents and provided embedded links for

the FDA submission using ODS PDF.

. Created CRT's for NDA's electronic submission to the FDA.

. Developed reports using Proc (Report, Tabulate and Print).

. SAS was used for pre-processing data, SQL queries, data analysis,

generating reports, and statistical analysis.

. Run weekly and monthly reports using SAS.

. Responsible for developing new SAS programs and modifying existing SAS

programs.

. Explained the purpose and functions of complicated SAS programs to non-

technical personnel.

EDUCATION

. Masters in Bioinformatics (Specialized in Computational Biology),

NJIT, NJ

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