Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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.htmlThis 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. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site ."Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."As an equal opportunity employer, we welcome applications from individuals with disabilities.We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.Reasonable AccommodationsIf you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accommodation for disability form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status.EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here .Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here .Minimum Salary: 120000.00
Maximum Salary: 140000.00
Salary Unit: Yearly