Principal Biostatistician (FSP)
LabCorp
Mechelen, Belgium
13 uur geleden
  • Principal Biostatistician required to work for Labcorp Drug Development in Phases I-IV
  • You will be employed by Labcorp Drug Development and work within our FSPx department 100% dedicated to one Sponsor
  • The Sponsor is a top 20 pharmaceutical company who has a strong and diverse product pipeline
  • Office based in any of our European or South African offices or home based anywhere in Europe or South Africa
  • You must be an experienced Lead Biostatistician experience gained within a CRO / Pharma / Biotech
  • Pro-active attitude, good communication and project management skills required
  • Discover new opportunities to grow your career as a Labcorp Drug Development FSP Principal Biostatistician. Our partner has an incredibly exciting and diverse pipeline including oncology, transplantation, urology and anti-infectives.

    The position offers a strong support network, flexible working solutions and the opportunity to raise your profile in the industry.

    If you are looking to strengthen your therapeutic expertise within oncology (alongside other therapy areas) whilst gaining exposure to a Bio-Pharmaceutical working environment this is a fantastic opportunity.

    This is an incredibly exciting time to be joining Labcorp Drug Development as we continue to grow and expand. This is a full-time home or office-based role anywhere within Europe or South Africa.

    What is FSP?

    At Labcorp Drug Development, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

    As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.

    Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp Drug Development has an FSP opportunity to match your area of expertise.

    Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp Drug Development studies.

    With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

    Further information can be found at :

    Job Primary Functions

    Lead complex studies such as NDA 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 DMC 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

    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

    Perform complex sample size calculations under the supervision of more senior statistical staff

    Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant

    Provide statistic input and review of the CSR for complex studies

    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 such as NDA submissions or complex, multi-protocol programs in order to win new business

    Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives

    Represent the department during audits.

    Job Qualifications

    Master’s degree, equivalent, or higher in Biostatistics or related field

    Previous experience of working as a Lead 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 , non-parametric analysis, linear and non-linear models, categorical data and survival analysis

    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

    Fluent in English language (both verbal and written).

    Looking to kick-start your career dedicated to improving health and improving lives? Then #JoinThePursuit.

    MORE INFORMATION AVAILABLE ON REQUEST

    For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457. To apply, please click on the APPLY button.

    Keywords :

    Covance, Covance by Labcorp, Labcorp Drug Development, FSP, Functional Service Provision, Clinical Analytics, FSPx, Adaptive Design, Umbrella, Platform, Bayesian analysis , Principal, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Study Biostatistician, pharma, pharmaceutical, Bloemfontein, Vienna, Brussels, Sofia, Prague, Paris, Berlin, Athens, Budapest, Dublin, Rome, Vilnius, Amsterdam, Warsaw, Lisbon, Bucharest, Moscow, Bratislava, Madrid, Bern, Basel, Kiev, Slough, Berkshire, London, England, Edinburgh, United Kingdom, Cambridge, Swansea, Sheffield, Manchester, Alderley Edge, Birmingham, home based, field based, home-based UK Anywhere, anywhere in England, anywhere in Scotland, anywhere in Wales, anywhere in Ireland, flexible location, CDISC, SDTM ADaM, Statistical Analysis Plan , study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, periodic safety update reports, oncology, rare diseases, Europe, cancer, Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, UK , #LI-PL1, #LI-Remote, Remote, EMEA

    Labcorp is proud to be an Equal Opportunity Employer :

    As an EOE / AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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