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Apply now for the position of Senior Biostatistician, and you will join a biostatistics teams responsible for research and development of cutting-edge immunodiagnostics
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Biostatistician, Pre-Market Biostatistics, you will be responsible for :
Recommending statistical methodology for the evaluation of analytical and clinical study data.
Interpreting and evaluating test data and results of complex studies and develops appropriate recommendations.
Performing detailed review of clinical study protocols and development plans to ensure that the appropriate sample size and statistical methods are specified to support study endpoints.
Developing the statistical components of plans and protocols for product development projects.
Ensuring that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and will result in generation of high quality data and analysis deliverables.
Interacting with members of the Data Management and Medical Affairs teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities.
Authoring Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan.
Developing statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports.
Participating in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals.
Providing complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
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.
Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). R programming experience is preferred.
Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical).
Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is a plus.
Experience with analysis of complex data from multiple data sources.
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 generalized audiences
Required skills to have for the success of this role
Minimum educational background of MS in statistics/biostatistics or other quantitative field. Exceptional candidates with backgrounds bridging biological science and biostatistics will be considered.
At least 5-8 years of experience in biostatistics supporting development of medical diagnostics/devices.
Strong knowledge and demonstrated experience in statistical modeling and simulation, clinical trial study design, statistical programming (R preferred), and data wrangling.
Demonstrated progressive responsibility and statistical expertise to support analytical and clinical verification studies from planning through regulatory submission.
• Candidate must be able to work legally in the United States. No sponsorship is available.
Who we are: We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at Careers - Siemens Healthineers USA (siemens-healthineers.com)
The pay range for this position is $120,000 - $140,000 U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. The annual incentive target is (8%) of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
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