Data Manager

SRI KANT

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

SUMMARY:

•Having 2.2 years of experience as a SAS Programmer.

•Extensive experience in extraction of large data in to SAS environment.

•Experience in creating SDTM datasets as per CDISC SDTM Standards.

•Experience in CDISC SDTM mapping of variables to make the raw data confirmed to SDTM model.

•Knowledge of Clinical Trial Data like Demographic Data (DM), Adverse Events (AE), Vital Signs (VS), and concomitant medication (CM) data.

• Having an experience in generating Tables and Adams.

•Create Analytical Datasets from raw datasets.

•Created Summary Tables and Adams according to the specifications of the study for statistical analysis.

•Experience on using of SAS Functions.

• Modify variable Attributes using options and statements in the DATA step.

• Use SAS functions to convert character data to numeric and vice versa.

• Having knowledge of various SAS products like SAS/Base, SAS/Macro, and SAS/SQL.

• Having knowledge of various SAS Procedures like PROC MEANS, PROC FREQ, PROC CONTENTS, PROC IMPORT, PROC FORMAT, PROC SORT, PROC REPORT, PROC TRANSPOSE, and PROC PRINT.

•Generate HTML reports using ODS statements.

•Recognize various system options that are available for macro debugging and displaying values of user-defined and automatic macro variables in the SAS log.

•Proficient in understanding of Study Protocol, Design document, SAP

(Statistical Analysis Plan), and CRF (Case report Form).

• Highly motivated and organized team player with good oral, written and communication skill.

ACCESSING DATA USING SQL :

•Generate detail reports by working with a single table or joining tables using PROC SQL and the appropriate options

•Generate summary reports by working with a single table or joining tables

using PROC SQL and the appropriate options

ACCESSING DATA USING MACROS :

•Created own macros to optimize code.

Tested and Debugging Existing MACROS.

Developed SAS codes with SAS/MACRO facility to improve the reusability of the codes.

Technical skills:

SAS Tools : SAS (Base SAS, Macros, Sql)

Database : Oracle

Operating System : Windows XP

PROFESSIONAL EXPERIENCE:

Company: Quintiles (Bangalore, India). 2013-2015

Role: STATISTICAL PROGRAMMER – I

PROJECT DETAILS:

Project : Phase-2 Clinical Trail.

Role : SAS Programmer.

Title : Anti Diabetic

Subjects : 98

Environment : SAS/Base, SAS/ Macros, Windows.

Description:

The objective of the study is to evaluate the hyperglycaemia response (the response to low blood sugar) in subjects with Type 1 diabetes. The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Responsibilities:

•Created datasets in SDTM (3.1.2) format and created analysis datasets.

•Involved in multiple projects and interacted with other Programmers, statisticians and data managers to analyse data.

•Developing the SAS programs for Adams & Tables for data review & presentation including CRTs as per CDISC, patients Adams mapping of safety database and safety tables.

•Experience in using Open CDISC Validator on SDTM domains to check compliance.

•Performed CDISC mapping for current trials and classified data into domains such as Demographics (DM), Disposition (DS), Medical History (MH), Adverse Event (AE) table etc.

•Generated Safety Tables, Adams which also involved in analysing data and generating Reports.

•Created reports using the PROC REPORT for the submission as per the FDA regulations and company standards.

•Formatted RTF reports using SAS/ODS (Output Delivery System).

•Proficient in understanding of Study Protocol, Design document, SAP

(Statistical Analysis Plan), and CRF (Case report Form).

•Highly motivated and organized team player with good oral, written and communication skill.

EDUCATIONAL QUALIFICATION:

•B.sc from Osmania University, India.

•Master’s in Chemistry from Osmania University, India.

•Master’s in Chemistry from Lamar University, Beaumont, TX

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