Developer Clinical Research

Resume

Abhineet Gaikwad.

*****-***************.****@*****.***

Mobille No: 844-***-****

To associate myself with a organization in which I can work to my highest potential and can make

significant contribution towards growth and benefit by exploring the creativity in me by applying my

knowledge.

• Strengths: Positive attiduded,good analytical skills,innovative,good,learning ability, excellent

organizational skills.

• Qualities: Can work effectively in a team and individually with minimal supervision, dedicated

and committed

1. Knowledge of Phase (I-IV) for clinical trials.

2. Good Knowledge of Clinical Research Management

3. Creation on analysis datasets from raw data using proc import and infile tequnieques and

modified existing datasets using Set, Merge and conditional statements .

4. Expertise in extracting manipulating data and creating datasets from various sources like

Exel,flat files using using proc import facility

5. Conversation of Characters in to Numeric values by using input and vice-versa using put

statement

6. Expertise in producing HTML,RTF,PDF formmated reports by using SAS/ODS.

7. Expertise in using SAS functions.

8. Expertise in generating reports using SAS Procedure PROC REPORT

9. Expertise in using PROC TRANSPOSE,PROC MEANS,PROC COPY,PROC

TEMPLATE,PROC FREQ,PROC TABULATE etc.

10. Expertise in converting XPT files to SAS and vice-versa

11. Good Knowledge of STDM-CDISC.

• TECENICAL SKILLS:

• Languages : SAS BASE

• Applications:Microsoft Office

• Operating System:Windows

• Internship Program:

ORGANIZATION:ClipLab –Cytel Clinical programming Labolatory.

Resume

• Analysis Dataset Development

1. Role Developer

2. Duaration :104 hrs

3. Description :Creation anaysis dataset in the frist step of Clinical Trial analytics

datasets.In this I performed role of developer to create analysis datasets. Was provided

with a raw datasetes from which I have crated analysis datasets by writing SAS code

bassed on specification provided.

• Analysis Dataset Validation:

1.Role : Validator

2. Duaration :56 hrs

3.Description: Accuracy of analysis datasets were checked by independent codes written by

developers .Developing a dataset and comparing that dataset with existing dataset provided

by developer utilizing proc compare to obtain validation findings.

• Data Integration for PK analysis

1.Role:Developer

2 Duration:48hrs

3.Description: In this assignment, I was provided with raw clinical datasets from which PK

analysis was needed to be created .Developing dataset from multiple datasets containing

laboratory values, Demographic, Baseline vital signs, Dose administration details, Blood

collection logs.

• Report Generation

1.Role:Developer

2.Duration:72 hours

3.description:For the interpretation of data and making statistical and clinical interfaces,

summary reports and listings were generated .Generating a mock up table according to

clients need. Generating the report using the proc report, the proc template to change RTF

output and applying ODS RTF to the report

• Report validation

1.Role: Validator

2.Duration:40 hours

3.Description: validating the report which was generated by developer and and Utilizing

the PROC compare in case of reports. independent codes are performed to ensure the

Resume

accuracy of reports created by developer . in this assignment I was provided with the RTF

reports to be validated.

• Graph Generation

1.Role:Developer

2.Duration:80 hours

3.Description:Summary reports are generally are usually supported by pictorial

reports(Graphs).Generating Graph for %change from baseline (Gmean+/-SE) for laboratory

test generating error bar graph for PK end point providing individual ratios Geometric

means and the confidence interval s of the treatment comparison.

• EXPRIANCE

Organization :Cytel Statistical Software PVT. LTD., Pune.

Designation: Internee

Duration:6 Months

• OTHER EXPRIANCE:

1 years of experience in Healthcare company as a Clinical Research Executive.

• Organization: Metropolis Healthcare Pvt .Ltd. Mumbai as Clinical Research Executive.

• Duration: June 2012-13.

• Job Profile:

• Preparation of study documents like Visit Schedule, Test Requisition Form, Laboratory

Instruction Manual etc.

• Maintenance/ documentation of different logs, like specimen status, Problem Data form,

Problem Specimen form etc.

• Monitoring the entire process of study specific test codes building in LIS.

• Preparation of report format & laboratory reference ranges.

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• Checking dummy run report and reference ranges with report format/chronological table

event/agreement paper.

• Verbal callouts for critical lab values.

• Report dispatch.

• Storage of raw information related to project

• Additional study related work assigned by PM/CRA

• EDUCATIOINAL DETAILS

Course School/College Board/University

SAS@

Cytel Statistical Sotware &

Base/Adv Projects

Services Pvt.Ltd

ance

Diploma in

Sysplex bioscience Completed

Clinical Research

M.Sc Dr.John Barnabas Post graduate

School of Biological Studies: Pune University

Biochemistry

Ahmednagar College

2011

Suryadatta college of

B.Sc management and information

Biotechnology20 Sikkim- Manipal university

technology

09

H.S.C

Kisanveer college,Wai Kolahpur Board

2006

SSC 2004 Dravid High School,Wai Kolahpur Board

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• PERSONAL DETAILS

Date of Birth - 09/12/1987

Age - 26

Gender - Male

Marital status - Single

Nationality - Indian

Passport Number-K 6842879

Permanent Address- Sector no-11 703 New Krishna tower, B-wing in front of Mega mart,

Khoparkharne, New Mumbai.

• Declaration

I do hereby confirm that the information furnished in this is true to the best of my knowledge

and belief.

• Place: Mumbai

Resume

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