Pre-market Biostatistician Siemens Healthineers is seeking a Biostatistician to join our Healthcare Diagnostics business based in Llanberis. The collaborative Biostatistician role comes with an attractive salary and a positive workplace culture. As our Statistician, you will serve as a subject matter expert in biological statistics to support a variety of activities related to the development of automated immunoassay products. This is a primarily a home based role with some travel to our site. To give you an idea of how this flexible role would look and feel, here are some of the tasks you could expect to do: · Apply statistical methods to collect, organise, analyse and interpret data and apply statistical principles to design and analyse multi-variable experiments. · Prepare reports to document statistical outputs. · Develop processes and tools with regard to statistical matters. · Educate staff on the use of statistical techniques and how they can apply to routine activities. The role will leverage knowledge and experience in the areas of statistical techniques and programming to support product development goals within the Laboratory Diagnostics Division. The Pre-market Statistician will be responsible for providing technical expertise in biostatistics and to lead statistical evaluations of analytical and clinical validation studies for new in vitro diagnostics devices developed by Siemens Healthineers Laboratory Diagnostics. The role will provide significant statistical consulting to product development projects, conduct training, and contribute to development of reports, technical documents and procedures pertaining to statistical methods. To apply, you will need to have gained a post-graduate degree in in statistics or biostatistics and have significant working experience in biostatistics. Preferred candidates will have skills and experience required to support analytical and clinical verification studies for immunoassays for use in allergy diagnosis, infectious disease, clinical chemistry, oncology and/or veterinary applications. Previous experience supporting FDA regulated clinical trials environment is desired. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered. Other desired skills and attributes include: · Strong knowledge of experimental design and clinical trial methodologies · Demonstrated statistical expertise to support analytical and clinical verification studies from planning through regulatory submissions · Demonstrable experience in SAS Programming and with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical). · Demonstrated progressive responsibility and statistical expertise to support analytical and clinical verification studies from planning through regulatory submissions. · Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations. Familiarity with diagnostic clinical trial statistics is required. · Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems. · Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is required. · Experience with analysis of complex data from multiple sources. Knowledge and experience using CDISC data standard models (CDASH, STDM, and ADAM). · Ability to work independently and in project teams. Highly motivated and driven to exceed expectations. · Strong communication skills in English, written and spoken. Strong ability for public speaking in audiences with mixed backgrounds. Able to distill complex statistical concepts in simpler terms to generalised audiences. If this job in Llanberis excites and motivates you, then please apply today. We'd love to hear from you. Siemens Healthineers has been Certified™ as a ‘great place to work’. We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, please explore our website. Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience, and digitalising healthcare. We embrace and encourage different viewpoints, backgrounds, experiences and encourage our employees to be themselves and empower them to unleash their true potential. This allows diverse ideas and inclusive approaches to thrive every day. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Products Ltd Experience Level: not defined Full / Part time: Full-time