Clinical Biostatistician – Danaher – København

In our line of work, life isn’t a given – it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us – no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight – it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The departmentThe Clinical & Medical Affairs function (C&MA) develops and implements the Clinical Evidence and Medical Affairs strategies and provides leadership on all medically related strategic decisions to the overall Radiometer business strategy.We have a good pipeline of studies planned, and we expect our new colleague will be engaged in analytical performance and Real-World Evidence studies related to Immunoassay/Biochemistry, Cardiology, and hematology to name some examples.Your responsibility embraces vital insights to the help organization growThe main responsibility for this role is to be responsible for all statistical aspects of designing, statistical programming, analyzing, and reporting of clinical studies globally in a range of different product areas throughout the product lifecycle in a global environment.This includes:Consulting with the project teams and apply statistical expertise to ensure scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies and project teamsProvide statistical support to assist with sample size calculations and development of the statistical analysis plan (SAP) for clinical studies and complete SAP throughout lifecycle of the studyPerform data review and statistical analyses. Collaborate in writing statistical sections for integrated reports or/and statistical reportsDevelop statistical programs to perform analyses and prepare data displays by developing standards to ensure quality in standard work incl. dataset structures, macros, and programs for analysesContribute to ad hoc explorative analyses for internal understanding, collaborate to generate health economics evidence and publicationsAnother primary function is to represent Bioinformatics in cross-functional study teams and proactive contribute to biostatistical advice in line with guidelines and state-of-the art methodologies.You are also encouraged to collaborate with other functions (data management, regulatory, quality, R&D, Marketing and Operations) as well as external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables.Finally, you are responsible to participate in development of the case report form (CRF) and database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.Your team covers many partnersYou will be joining the Bioinformatic Team (BIT) in a position and reporting directly to the Senior Manager.The department is deeply involved in applying data from clinical studies and surveillance for the benefit of patients in close collaborations with colleagues from C&MA, and other key partners both across and outside Radiometer. The Biostatistician will be part of a cross-functional team consisting of Data Specialists, a Data Scientist and Medical Writers.The Manager explains: “To succeed in this role you are curious and want to understand how Radiometer (end-to-end) can build the bridge between the clinics/hospitals with our products to the benefit of the patients in close cross-functional collaboration”Your strong skills make you stand outWe picture the right candidate holds a minimum of five year’ experience in biostatistics in medical device, pharmaceutical and/or academia.You possess deep knowledge about design of clinical trial, statistical methodologies, statistical programming, and interpretation and presentation of complex statistical results. You have experience with proactive planning, analyzing, and reporting of clinical studies for clinical diagnostics and/or medical devices e.g., precision, stability, and clinical sensitivity specificity studies.On top of that we are looking for someone who has some or all the below qualities:Align with data integrity standards and business ethics requirementsHaving appropriate skills, training, and integrity to tackle responsibility to innovate the way we collect, clean, store and analyze clinical and real-world dataUse our internal systems within standard work to systematically measure/report/improve the overall clinical study processFollow state-of-art with biostatistics in general and especially within medical devices and update Quality Instruction within global standardsThe ideal candidate will have a proven track record of successful results and in leading collaboration in effective teams and getting work done through others.You have an ability to understand complex scientific, engineering and business concepts, and with your analytic and systematic way of working easily navigate in the cross functional environment and to work independently and with authority.ApplicationWe continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application.We encourage you to apply before end of business on 1st October 2022. If you have questions, feel free to contact Chief of Clinical Affairs & Bioinformatics, Lisbet Bærentzen at lisbet.barentzen@radiometer.dk. We look forward to seeing your application.We thank you for your interest. Please read our Applicant Data Privacy Notice carefully HybridAt Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.DanaherWhen you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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