Job Description

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 is responsible designing and implementing state of the art solutions with ability to own and drive a task, desire to drive/lead. The selected candidate will lead a small team of data specialists and provide them the required management and Leadership support. This position is part of the located in and will hybrid working model [ Partly from office and partly from home] . At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. The selected candidate will report into the C&MA dept manager at Copenhagen and will have dottedl line report in to the Site Leader of Radiometer IDC team. T he department is deeply involved in applying data from clinical studies and surveillance for the benefit of patients in close collaborations with colleagues from CMA, and other key partners both across and outside Radiometer. The Biostatistician will be part of a cross-functional team consisting of Data Specialists and Medical Writers. In this role, you will have the opportunity to: Manage the data management delivery team and develop the capability for the group to support the existing workload while building expanding the capability as necessary 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 teams. Provide 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 study. Perform data review and statistical analyses. Collaborate in writing statistical sections for integrated reports or/and statistical reports. Develop 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 analyses. Contribute to ad hoc explorative analyses for internal understanding, collaborate to generate health economics evidence and publications. Mentor and assist with the growth of of the team by recruiting, developing, and retaining the talent. The essential requirements of the job include: 8 to 10 years of experience as a Data manager in clinical data management and shall have experience in data management plan design and also leading small teams. The 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. 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. Formal Education, Skills & Experience Masters Degree in Biostatistics or Bioinformatics / Bachelors in Bio-medical engineering with strong background in biostatistics or health care related fields. Strong familiarity with EDC and Clinical Data Management Systems such as Medidata Rave is preferred Having appropriate skills, training, and integrity to tackle responsibility to innovate the way we collect, clean, store and analyze clinical and real-world data. Experience in validation of statistical scripts. Experience in data visualization tools. Align with data integrity standards and business ethics requirements. When 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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