Statistical programmer

Megha Kothari

Email: **************@*****.***

Mob: 919*********

CAREER OBJECTIVE

To make a progressive career as a SAS programmer in an esteemed organization where I can

apply my experienced knowledge in the field of SAS programming for helping the growth of the

organization

PERSONAL SUMMARY

• Three years of experience in SAS programming of statistical reports, clinical database and

statistical analysis for clinical trials

• Experienced in the CDISC standard and the development of SDTM and ADAM datasets

• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/GRAPH.

• Worked with Statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings

and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating

Procedures (SOPs) and departmental guidelines.

• Experience in developing, validating and implementing SAS programs and produce derived

datasets for analysis and generating & documenting tables, listings and graphs for clinical study

reports.

• Excellent knowledge of SAS Procedures: PROC FREQ, PROC UNIVARIATE

• Generated reports using PROC REPORT, DATA _NULL_ and PROC TABULATE for

customized report writing.

• Experience in producing RTF, HTML files using SAS ODS.

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

and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11.

• Strong communication skills and can work well in a team.

• Proven ability to manage multiple assignments and handle changing priorities in a fast-paced

environment

• Certified Base SAS Programmer

PROFESSIONAL EXPERIENCE

Cytel Statistical Software and Services Pvt Ltd, Pune, Maharashtra, I ndia

Statistical Programmer March 2011 – Present

E nvironment: SAS 9.2, SAS Enterprise Guide, SAS/SQL, SAS/BASE, SAS/MACROS,

SAS/GRAPH, windows

• Developed SAS programs and generated safety and efficacy statistical tables, listings and figures

• Experienced in the CDISC standard and the generation of SDTM and ADAM dataset

• Currently working on SDTM, ADAM analysis dataset creation.

• Development of PK concentration datasets

• Report Generation – AE tables, PK related outputs, V ital Signs and Laboratory

t ables and listings etc.

• Report Validation

• Graph generation – Concentration Vs time plots, etc.

• Worked on Oncology t r ials

• Communicating with clients on database development and TFLs development issues

• Quality control for datasets, Analysis datasets and TLF’s

• Consistent use of Proc Report, Proc Tabulate, SAS functions, macros, Proc SQL, etc.

Clip Lab - Cytel Statistical Software and Services, Pune, Maharashtra, I ndia

Intern October 2010 – March 2011

Projects in Clip Lab:-

• Analysis Dataset Creation.

• Validation of Analysis Dataset by Independent

P rogramming.

• Programming Graphs (e.g. Serum Creation

Concentration against Time)

• Merging Datasets for Pharmaco-kinetic

A nalysis.

• Report Generation – AE, Demo.

• Validation of Tables by Independent

p rogramming.

EDUCATION

BASE SAS Certified September 2011

Ult ramax I nfonet Technologies Pvt. Ltd. P une, Maharashtra

Clinical BASE SAS Training October 2010

I nternational I nstitute of I nformation Technology ( I I I T) Pune, Maharashtra

Advanced Post Graduate Program in Biotechnology Management A ug 2010

Pune University Pune, Maharashtra

Bachelor of Biotechnology J une 2008

TECHNICAL QUALIFICATIONS

• Certified Base SAS Programmer Training – Completed

• SAS, Excel, Word, PowerPoint

ACT IV I T I ES & I N TERESTS:

Activities:

• Successfully organized ‘Intellectual Property Awareness Day’ event at IIIT, Pune.

• First prize in ‘Eureka’09’ Exhibition on New Product Development (IIIT, Pune).

• Attended workshop on “Simulation and optimization of processes” by Intelligen, Inc. at International

Institute of Information Technology.

• Participated in ABCS-09 (Annual Biotechnology Conference For Students 2009).

• Participated in Bioinformatica Indica’08, In ternational Symposium on Computational

B iology

I nterests: A r t (Drawing & Painting)

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