Job Description

In our line of work, life isn\xe2\x80\x99t a given - it\xe2\x80\x99s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we\xe2\x80\x99re located. Creating impactful innovations like ours, doesn\xe2\x80\x99t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we\xe2\x80\x99re working at the pace of change to improve patient lives with diagnostic tools that address the world\xe2\x80\x99s biggest health challenges.

The Department

The Clinical & Medical Affairs function (CMA) develops and implements the Clinical Evidence and Medical Affairs strategies and provides leadership on all medically related strategic decisions to the overall Radiometer business strategy.

We have a good pipeline of studies planned, and we expect our new colleague will be engaged in analytical performance and Real-World Evidence studies related to Immunoassay/Biochemistry, Cardiology, and hematology to name some examples.

Your responsibility embraces vital insights to the help organization grow

The main responsibility for this role is to be responsible for all statistical aspects of designing, statistical programming, analyzing, and reporting of clinical studies globally in a range of different product areas throughout the product lifecycle in a global environment.

This includes:

• Consulting with the 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 development of the statistical analysis plan (SAP) for clinical studies and complete 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 to perform analyses and prepare data displays by developing standards to ensure quality in standard work incl. dataset structures, macros, and programs for analyses
• Contribute to ad hoc explorative analyses for internal understanding, collaborate to generate health economics evidence and publications

Another primary function is to represent Bioinformatics in cross-functional study teams and proactive contribute to biostatistical advice in line with guidelines and state-of-the art methodologies.

You are also encouraged to collaborate with other functions (data management, regulatory, quality, R&D, Marketing and Operations) as well as external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables.

Location

You will be joining the Clinical Evidence Analytics and Reporting Team (CLEAR) in a Biostatistician position and reporting directly to the Senior Manager in Copenhagen Denmark and dotted line into the Radiometer IDC team at Bengaluru India. We work on a hybrid model meaning partly from home and partly from office (India Development centre - Bengaluru) based on business requirements and offers very good flexibility and a great working environment.

The department is deeply involved in applying data from clinical studies and surveillance for the benefit of patients in close collaborations with colleagues from CMA, and other key partners both across and outside Radiometer. The Biostatistician will be part of a cross-functional team consisting of Data Specialists and Medical Writers.

Skills & Qualifications

Minimum of 5 years of Experience

Bachelors or Master\'s Degree in Statistics Preferrable

Competent in SAS programming language and/or R.

Review/write sections of Statistical analysis reports or CSRs

Good Experience in using Statistical tools and MS Office.

A minimum of 3 year\xe2\x80\x99 experience in biostatistics in medical device, pharmaceutical and/or academia.

You have experience with proactive planning, analyzing, and reporting of clinical studies for clinical diagnostics and/or medical devices e.g., precision, stability, and clinical sensitivity specificity studies.

Qualities

Align with data integrity standards and business ethics requirements.

Having appropriate skills, training, and integrity to tackle responsibility to innovate the way we collect, clean, store and analyze clinical and real-world data

Use our internal systems within standard work to systematically measure/report/improve the overall clinical study process.

Follow state-of-art with biostatistics in general and especially within medical devices and update Quality Instruction within global standards.

The ideal candidate will have a proven track record of successful results and in leading collaboration in effective teams and getting work done through others.

You have an ability to understand complex scientific, engineering and business concepts, and with your analytic and systematic way of working easily navigate in the cross functional environment and to work independently and with authority.

Travel : 10%

When you join us, you\xe2\x80\x99ll also be joining Danaher\xe2\x80\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\xe2\x80\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you\xe2\x80\x99ve ever wondered what\xe2\x80\x99s within you, there\xe2\x80\x99s no better time to find out.

Danaher