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  • Posted: Feb 6, 2023
    Deadline: Not specified
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  • As the drug development business of Laboratory Corporation of America Holdings (Labcorp) and the world’s most comprehensive drug development #CRO service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. Because of our broad experience and specialized expertise, we’re i...

     

    Senior Biostatistician (CDS)

    Description

    • Senior Biostatistician required to work for Labcorp Drug Development in a Lead role
    • Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
    • This is a permanent full-time role, either office based or home based anywhere in Europe or in South Africa
    • You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company

    Job Primary Functions

    • Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
    • Perform project management activities for identified projects including resource planning, timelines and milestone management
    • Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
    • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
    • Conduct overall statistical review of TFLs for complex studies prior to client delivery
    • Review CRF and other study specific specifications and plans
    • May perform sample size calculation for simple studies under the supervision of more senior statistical staff
    • Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
    • Provide statistical input and review of the CSR for medium complexity studies
    • Preparation and review of randomization specifications and generation of randomization schedules
    • Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
    • Present and share knowledge at team meetings and/or at monthly seminars
    • Attend bid defense meetings for medium complexity studies in order to win new business
    • Represent the department during project-driven client audits.

    Job Qualifications

    • Master’s degree, equivalent, or higher in Biostatistics or related field
    • You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company
    • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
    • Ability to effectively communicate statistical concepts
    • A good knowledge of the overall clinical trial process
    • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
    • You must be fluent in English language (both verbal and written)

    go to method of application »

    Biostatistician 2 (CDS)

    Description

    • Biostatistician 2 required to work for Labcorp Drug Development supporting the Lead Biostatistician
    • Opportunity to develop into a Lead Biostatistician and beyond
    • Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
    • This is a permanent full-time role, either office based or home based anywhere in Europe or in South Africa
    • You must have some previous experience of working as a Biostatistician within clinical trials

    Job Primary Functions

    • Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings
    • Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate
    • Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff
    • Perform statistical analysis for medium complexity studies
    • Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery
    • Review CRF and other study specific specifications and plans
    • May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff
    • Provide statistical input and review of the CSR for simple studies
    • Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff

    Job Qualifications

    • Master’s degree, equivalent, or higher in Biostatistics or related field
    • Ability to program in one or more statistical software packages (SAS® preferred) used to conduct statistical analyses
    • Ability to effectively communicate statistical concepts
    • Interpersonal and effective communication skills
    • Cooperative and team-oriented
    • Self-motivation
    • The ability to work to tight deadlines while maintaining high standards
    • You must be fluent in English language (both verbal and written)

    go to method of application »

    Principal Biostatistician, Single Sponsor, Home or Office-Based

    In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your multidisciplinary global project team.

    • This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise and your work as a Biostatistician has a direct impact on improving the health and lives of thousands of patients around the globe every day. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!

    What else can you expect from us?

    • Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
    • Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
    • A genuine work life balance
    • Flexibility in working hours
    • A thorough onboarding with support from your personal mentor
    • A permanent employment contract with Labcorp Drug Development
    • Excellent training and career development opportunities, as well as support with advancing your individual education
    • Strong support from your Labcorp Line Manager and your team, as well as from more than 20,000 colleagues worldwide

    Your Responsibilities

    • Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
    • Perform project management activities for identified projects including resource planning, timelines and milestone management
    • Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
    • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
    • Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
    • Review Case Report Form and other study specific specifications and plans
    • Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
    • Preparation and review of randomization specifications and generation of randomization schedules
    • Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
    • Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
    • Attend bid defense meetings for complex studies
    • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
    • Represent the department during audits.

    Your Profile

    • Degree in a relevant field such as statistics, computer sciences, etc.
    • Solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
    • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
    • Proven professional experience with SDTMs, ADaM datasets and TFLs
    • Proven ability to effectively communicate statistical concepts
    • A good knowledge of the overall clinical trial process
    • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
    • Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
    • Business fluency in English – both verbal and written – is a must

    Method of Application

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