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    Satish Kumar Objective: Strong A

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    MuraliNaidu
    Satish Kumar is seeking a position as a Research Associate focusing on clinical research and product development. He has over 10 years of experience in clinical data management and analysis using SAS. He is proficient in OpenClinica for clinical data entry and management. Kumar has extensive skills in statistical modeling, report generation, clinical trial data analysis, and experience working in compliance with FDA and ICH guidelines.

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    Satish Kumar Objective: Strong A

    Uploaded by

    MuraliNaidu
    69 views4 pages
    Satish Kumar is seeking a position as a Research Associate focusing on clinical research and product development. He has over 10 years of experience in clinical data management and analysis using SAS. He is proficient in OpenClinica for clinical data entry and management. Kumar has extensive skills in statistical modeling, report generation, clinical trial data analysis, and experience working in compliance with FDA and ICH guidelines.

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    Satish Kumar is seeking a position as a Research Associate focusing on clinical research and product development. He has over 10 years of experience in clinical data management and analysis using SAS. He is proficient in OpenClinica for clinical data entry and management. Kumar has extensive skills in statistical modeling, report generation, clinical trial data analysis, and experience working in compliance with FDA and ICH guidelines.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    69 views4 pages

    Satish Kumar Objective: Strong A

    Uploaded by

    MuraliNaidu
    Satish Kumar is seeking a position as a Research Associate focusing on clinical research and product development. He has over 10 years of experience in clinical data management and analysis using SAS. He is proficient in OpenClinica for clinical data entry and management. Kumar has extensive skills in statistical modeling, report generation, clinical trial data analysis, and experience working in compliance with FDA and ICH guidelines.

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    © All Rights Reserved
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    Download as doc, pdf, or txt
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    Satish kumar

    294, 1st Cross Cambridge Layout, BANGALORE 560 008, INDIA


    Residence Phone: +91 80 51255737 Telefax: +91 80 25301614
    Mobile & SMS: +91 9912868928 Email: [email protected]
    OBJECTIVE
    To obtain a Research Associate position at a biotechnology firm / basic research
    lab focusing on Clinical Research and product development.
    SUMMARY

    I am a highly driven and result oriented professional with multi-disciplinary and


    cross-functional experience seeking a challenging and growth-oriented position
    that utilizes my knowledge of Statistical Analyses and SAS programming in a
    Clinical background

    Strong

    ability

    to build statistical models using a broad array of statistical

    techniques including general linear models, factor analysis, incomplete design,


    mixed effects, principal components analysis and other multi-variate designs

    Involved in extracting internal and external data, report generation using extensive
    SAS procedures.

    Thorough knowledge of Clinical Trials data like Demographic data, Adverse


    Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data)

    Experience in Clinical Data Analysis, Producing Reports, Listings, Tables, Case


    Report Tabulations, Summaries and Graphs from clinical trial data.

    Created complex and reusable Macros and extensively used existing macros for
    Data Cleaning, Validation, Analysis, Report generation, and Integration of Data.

    Expert in using SAS ODS to create HTML, RTF and PDF output files and Data
    _Null_ to generate ad hoc and customized reports.

    Good comprehension of FDA and CDISC guidelines, Good Clinical Practice


    (GCP), International Conference of Harmonization (ICH) and other regulatory
    guidelines (NDA including an ISE and ISS).

    Worked under 21 CFR part 11 complaint Lab

    Knowledge on Good Clinical Data Management(GCDMP)

    SKILLS
    LANGUAGES: OPEN CLINICA 2.0, SAS (9.1.3).

    OPEN CLINICA 2.0


    Data Plan:

    Defining
    Defining
    Defining
    Defining

    programs,
    Organization Units,
    Regions,
    Studies.

    Submit Data:

    Add Subjects
    Add new study events
    Validate data
    Entering data

    Manage Data:

    Manage Data
    Set User role
    Manage Subjects
    Creating Study events

    Data Entry:
    Discrepancy Management:
    Database Closure (Locking).

    SAS (9.0, 9.1.3): (Base, STAT, Proc SQL, MACRO, GRAPH).

    SAS procedures: SAS Procedures familiar

    SAS Enterprise Guide 4.1


    OTHERS:
    Data bases: Oracle Clinical 4.5
    Operating System: Windows 98/2000/xp.
    Tools: MS Excel, MS Word, MS PowerPoint.

    QUALIFICATION HIGHLIGHTS
    Highly inquisitive, intellectually curious, creative and resourceful
    Excellent skills in communication and collaboration
    Skilled in all phases of hybridoma production
    Solid working knowledge of immunology
    Excited by the challenge of research and experimentation
    EDUCATION

    WORK EXPERIENCE
    Professional Experience :

    Client: Clinnovo research labs Pvt Ltd

    Mar08-Till Date

    Position: Trainee clinical data coordinator


    Clinnovo research labs Pvt Ltd is a comprehensive strategic service provider for clinical research, healthcare and pharmacy
    R&D.My job responsibilities includes delivering quality clinical trial design and development. I had undergone training in
    CLINICAL DATA MANAGEMENT, where I came to know about the clinical data flow and working with database like open
    clinica and also I trained in clinical data analysis by using SAS.

    Personal details
    DOB:
    Languages Known: English, Hindi and telugu.
    Current Address:
    Phone no:
    Email : -.
    3

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