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Staff Biostatistician

  • Anywhere

Company :
Leica Biosystems

Location :
York, New York

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
Join our global team of talented people who are transforming the cancer diagnostics industry as a Staff Biostatistician! At Leica Biosystems, you will be stimulated by challenging work and inspired to learn every day. As a Leica Biosystems associate, you ll help develop solutions that enable accurate diagnoses to turn anxiety into answers. The Staff Biostatistician prepares and executes the biostatistical clinical study tasks, including: statistical analysis plan and analyses and data reporting, clinical study designs for in-vitro diagnostics and medical device products. The Staff Biostatistician represents the clinical group on multi-functional core teams to ensure the project requirements are met and clinical trials are conducted successfully according to established policies, standard work and industry guidelines. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies. Major Responsibilities (other duties may be assigned): * Consult with project teams and apply statistical expertise to ensure the scientific validity and proper design of studies in support of design and development activities. * Provide statistical support as needed to assist with sample size and data analyses for clinical trials. * Work cooperatively with scientists to design experiments for identifying critical factors, sources of variation and optimization studies. * Develop the statistical analysis plan (SAP) for clinical studies and execute SAP throughout lifecycle of the study. * Perform data review and statistical analyses. Collaborate writing statistical sections for integrated reports or/and statistical reports. * Comply with data integrity standards and business ethics requirements. * Develop statistical programs as necessary to perform analyses and prepare data displays. * Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. * Keep abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings. * Ability to multi-task, manage multiple protocols, and participate on multiple teams at the same time. Education and Experience: * The qualified candidate must have a PhD with 4+ years’ experience, or a Master s degree (Biostatistics or equivalent) with 7+ years of experience within a pharmaceutical or medical device environment. * Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations. * Familiarity with diagnostic clinical trial statistics is a plus. * Expertise in SAS is required. Minimum 5 years of experience in full time SAS programming in the biomedical industry. Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc. * Familiarity with Excel, MS Access and Visual Basic is a plus. * Familiar with FDA guidelines and other regulatory requirements is a plus. * Knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods. * Familiar with FDA guidelines and other regulatory requirements. * Must be highly-motivated, team-oriented, and organized with a strong attention to detail. Travel: * Up to 10% Check out our benefits here: All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.