Biostatistician to build and lead Radiometer’s standards for Biostatistics

Description

You might be sitting with many ideas and a lot of motivation to drive the discipline of biostatistics. This is your chance to become our first internal Biostatistician that will contribute and advice on some of our most important development projects, influencing our strategy on how we obtain the most relevant medical claims.

We are a leading provider of technologically advanced acute care solutions with more than 3,400 employees worldwide (1,100 in our Headquarters in Copenhagen/Brønshøj).

Welcome to Clinical & Medical Affairs in Radiometer’s R&D organization

You report to Director of Clinical Research, Fredrik Ceder, who works closely with the Clinical Operations team and the Medical Affairs team to set the direction for the strategy of our clinical studies. Using your statistical and Life Science expertize you can expect to become a vital advisor for the team. Your many R&D-, Regulatory Affairs- and Marketing colleagues are also looking forward to working with you to develop our products in order to help caregivers even more in making diagnostic decisions that save lives.We have a good pipeline of studies planned and we expect that you will be engaged in studies related to Immunoassay/Biochemistry, Cardiology and hematology to name some examples.

Duties & Responsibilities:

- Provide statistical input 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 calculations and data analyses for clinical studies. - 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 in writing statistical sections for integrated reports or/and statistical reports.- Develop 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.- Keep abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits.Application deadline

Application deadline is Friday 26 July 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site or alternatively apply quick and simple through LinkedIn. Please attach your CV and other relevant documents. We look forward to receiving your application.For further information, please contact Director, Clinical Research, Fredrik Ceder at tel. +45 2760 4295.

Qualifications

We believe that you have a strong drive to be part of building the biostatics function in Radiometer and that you are motivated to join a team that is evolving, growing and influencing the business in new ways. This combined with the following increases your chances of success:- The qualified candidate has a Master’s degree or PhD with at least 2 years' experience within biostatistics from the life science industry - Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations- 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 in English.The following qualifications are an advantage:- Expertise in SAS. Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc.- Familiarity with diagnostic clinical trial statistics - Familiarity with MDR, IVDR, FDA guidelines, and other regulatory requirements.

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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Organization: Radiometer
Job Function: Science
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time

Kilde: Jobnet.dk