Beckman Coulter Diagnostics
New York, New York
|Date Posted||January 19, 2023|
|Job Status||Not Specified|
Description:Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Senior Biostatistician for Beckman Coulter Diagnostics is responsible for analyzing data from our medical laboratory devices used to measure the concentration of certain substances within samples of serum, plasma, urine and/or other body fluids. Substances analyzed through these instruments include certain metabolites, electrolytes, proteins, and/or drugs. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
This position is part of the Department of Global Clinical Affairs -Biostatistics & Data Management and will be remote. You will be a part of the Biostatistics team and report to the Manager of Biostatistics responsible for 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.
If you thrive in a multifunctional and fast paced role and want to work to build a world-class Global Clinical Affairs – Biostatistics and Data Management organization—read on.
In this role, you will have the opportunity to:
Participate in development of 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.
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 essential requirements of the job include:
Master’s degree (Biostatistics, Statistics, Mathematics) with 2+ years’ of experience within a pharmaceutical or medical device environment, Or PhD with 0+ years' experience
Strong proven knowledge of statistical theory, experimental design (DOE) and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
Expertise in SAS is required with solid working knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc.
Must be highly motivated, team-oriented, and organized with a strong attention to detail.
Demonstrated ability to write documentation and understand, interact, and communicate effectively with others.
It would be a plus if you also possess previous experience in:
Familiarity with diagnostic clinical trial statistics
Familiar with FDA guidelines and other regulatory requirements
Familiarity with In-Vitro Device statistics
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
The salary range for this role is $110-125K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in Colorado/California. This range may be modified in the future.
This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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