Danaher Corporation Manager of Biostatistics in Danvers, Massachusetts
Danaher Company Description
Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. VisitLeicaBiosystems.com for more information.
Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
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Manager of Biostatistics will be responsible for the technical and administrative function of Biostatistics providing support to the Clinical Affairs or/and other departments. This position is responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of biostatistics for pre-market and post-market programs. * Oversees internal and external department infrastructure and staffing. * Assign biostatistics activities required for the planning /execution / reporting /closeout of clinical trials, ensuring that applicable policies, procedures and regulatory standards are followed. * Leverages industry standards and best statistical practices and establishes common systems/processes/tools for statistical inference. * Maintains and/or establishes Standard Operating Procedures (SOPs) and a measurable process to build knowledge and ensure compliance with all applicable company policies, procedures and regulatory standards. Drives continuous process improvement. * Cultivates a positive work environment that reflects company values, embraces collaboration across functions and businesses, and promotes associate development. * * Provide guidance on statistical support to clinical team, study projects, and data management. * Consult with 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. * Establish excellent collaboration with scientists to design of experiments for identifying critical factors, sources of variation and optimization studies.
* Develop the statistical analysis plan (SAP) for a 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. * Develops statistical programs as necessary to perform analyses and prepare data displays. * Participate in developing the case report form (CRF). * Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. * Comply with data integrity standards and business ethics requirements. * Keeps abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
* The qualified candidate will 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. * Must be highly-motivated, team-oriented, and organized with a strong attention to detail. * Must have the ability to write documentation and understand, interact and communicate effectively with others.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Leica Biosystems
Job Function: Science
Primary Location: North America-North America-United States-MA-Danvers
Req ID: ADV000961