Senior Biostatistician (Medical Devices)

<ul><li><b>Senior Biostatistician</b> r<span>equired to work for Labcorp Drug Development in a Lead role</span></li><li>Working with multiple Sponsors across several therapeutic areas within medical devices</li><li>This is a permanent full-time role, either office based or home based anywhere in Central and Eastern Europe or in South Africa</li><li>You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company</li></ul><p></p><p>Join our growing team and discover your extraordinary potential by working as a Labcorp Drug Development <b>Senior Biostatistician.  </b>You will enjoy a varied role working for different sponsors across several therapeutic areas within medical devices, leading projects and mentoring junior members of the department.  The position offers an excellent support network with access to Labcorp Drug Development’s statistical consultants, flexible working solutions and the opportunity to progress your career.  If you are looking to strengthen your Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity. </p><p></p><h2><u>Job Primary Functions</u></h2><ul><li><p>Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings</p></li><li><p>Perform project management activities for identified projects including resource planning, timelines and milestone management</p></li><li><p>Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff</p></li><li><p>Perform complex statistical analyses, quality check statistical analyses developed by other statisticians</p></li><li><p>Conduct overall statistical review of TFLs for complex studies prior to client delivery</p></li><li><p>Review CRF and other study specific specifications and plans</p></li><li><p>May perform sample size calculation for simple studies under the supervision of more senior statistical staff</p></li><li><p>Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant</p></li><li><p>Provide statistical input and review of the CSR for medium complexity studies</p></li><li><p>Preparation and review of randomization specifications and generation of randomization schedules</p></li><li><p>Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department</p></li><li><p>Present and share knowledge at team meetings and/or at monthly seminars</p></li><li><p>Attend bid defense meetings for medium complexity studies in order to win new business</p></li><li><p>Represent the department during project-driven client audits.</p></li></ul><p></p><h2><u>Job Qualifications</u></h2><ul><li><p>Master’s degree, equivalent, or higher in Biostatistics or related field</p></li><li><p>You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company</p></li><li><p>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</p></li><li><p>Ability to effectively communicate statistical concepts</p></li><li><p>A good knowledge of the overall clinical trial process</p></li><li><p>Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc</p></li><li><p>You must be fluent in English language (both verbal and written)</p></li></ul><p></p><p><span>Looking to kick-start your career dedicated to improving health and improving lives? Then </span>#JoinThePursuit.</p><p></p><h2>MORE INFORMATION AVAILABLE ON REQUEST</h2><p>For a confidential discussion about this opportunity, please phone Peter Lewis on +447917710602 To apply, please click on the APPLY button. </p><p></p><p>NO AGENCIES PLEASE</p><p></p><p><u>Keywords:</u></p><p>Labcorp Drug Development, Covance By Labcorp, Covance, Chiltern, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Lead Biostatistician, Study Biostatistician, Bloemfontein, Sofia, Prague, Budapest, Vilnius, Warsaw, Bucharest, Bratislava, home based, field based, home-based, flexible location, CDISC, “Statistical Analysis Plan”, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, periodic safety update reports, medical device, devices, CEE, Central and Eastern Europe, Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, South Africa, #LI-PL1, #LI-Remote, Remote, EMEA</p><p></p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>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.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>