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  • Posted: Mar 9, 2022
    Deadline: Not specified
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    IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...
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    Senior Biostatistician - Center for Statistics in Drug Development

    Our biostatisticians support endpoint selection, sample size estimation and re-estimation, simulations, advise on state-of-the art design approaches and analysis methods, and assist with data displays and interpretations of data analysis results, based on machine learning or other complex data analyses. Our experienced biostatisticians serve as statistical consultants, both internally and externally, provide statistical thought leadership, and advise on advanced statistical methods. Their early engagement aims to identify gaps in the drug development strategy and in proposed study designs — at the time of synopsis writing.

    The CSDD group’s expertise in design types include biosimilars, adaptive designs, seamless designs, dose-response designs, master protocols, Bayesian methods and analyses. This group engages in publishing papers in peer-reviewed journals, refereeing and editorial work, and presenting talks at scientific conferences and at internal and external webinars.

    Job Overview:

    1. Develop statistical methods sections of protocols and review case report forms (CRFs).
    2. Prepare analysis plans and write specifications for analysis files, tables, and figures.
    3. Communicate with clients regarding study protocol or statistical analysis issues as they arise and communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
    4. Interpret analyses and write statistical sections of study reports.
    5. Accountable for controlling costs and maximizing revenue recognition.
    6. Performing protocol development, sample size calculation and CRF’s review’s
    7. Acting as a statistical team lead for single, complex studies or groups of studies
    8. Coordinating the development of statistical analysis plans, table shells, and programming specifications
    9. Managing scope of work and budget, providing revenue and resource forecasts
    10. Consulting on operational, statistical, and therapeutic area topics
    11. Preparing proposal text and attend bid defense meetings if needed
    12. Acting as a primary point of contact for the study team - communicate with team members regarding execution as it relates to timelines, budget, data quality, and interpretation of results
    13. Providing expert statistical input and review of deliverables for validation requirements
    14. Reviewing of the clinical study report to ensure statistical integrity in the reporting of the results
    15. Interpreting analysis and crafting statistical sections of integrated reports
    16. Providing training and mentoring to team members and department staff

    Requirements:

    1. PhD or MSc degree in Statistics, Biostatistics, or related field, along with 5 + years’ experience within the life-science industry, PhD preferred.
    2. Strong knowledge of complex or advanced statistical methods and good expertise in implementing and applying them in clinical trials
    3. Must have experience with clinical trial design, adaptive design strongly preferred
    4. Must have solid work experience in regulatory health authorities’ environment (FDA, EMEA,…) and with compliance within the pharmaceutical and CRO space.
    5. Strong working knowledge of SAS or R and CDISC SDTM and ADaM
    6. Ability to effectively manage multiple tasks and projects, ability to excel at communicating and explaining statistical concepts

    go to method of application »

    Statistical Programmer 2 - Global BIOS

    IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting.

    Job Overview:

    1. As a Statistical Programmer 2, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas. 
    2. Thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose.
    3. You will also provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs.
    4. You will plan and lead the development of project-related solutions to the full scope of statistical programming tasks.
    5. As a lead programmer on assigned studies, you will write and maintain programming specifications datasets and program TLFs, to maximize programming efficiency with the use of biostatistical tools and assist in training and mentoring new or junior team members

    Requirements:

    1. Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    2. 3+ years, statistical programming experience within the Life Science industry
    3. Experience as project lead, directly engaging clients and coordinating tasks within a programming team
    4. Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    5. Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
    6. Ability to independently lead multiple tasks and projects
    7. From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues. 

    What is in it for you?

    1. Global exposure
    2. Variety of therapeutic areas
    3. Collaborative and supportive team environment
    4. Access to cutting-edge in-house technology
    5. Excellent career development and progression opportunities
    6. Work-Life Balance

    Method of Application

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