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Senior Biostatistician in Miami, Florida at Beckman Coulter Diagnostics

Date Posted: 12/4/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/4/2018

Job Description

Job ID: BEC012771

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter 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.


Description

Senior Biostatistician will provide statistical support for 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.

Duties & Responsibilities:
-Provide 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.
-Provide statistical support to assist with sample size and data analyses for clinical trials. 
-Work cooperatively with scientists to design of experiments for identifying critical factors, sources of variation and optimization studies.  
-Participate in development of 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.

Job Requirements



Qualifications

-The qualified candidate will have a PhD with 0-2 years' experience, or a Master’s degree (Biostatistics or equivalent) with 3+ 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.
-Expertise in SAS is required.  Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc.
-Familiarity with diagnostic clinical trial statistics 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.  


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.


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.

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