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Are you an experienced Statistician and ready for the next step in your career?
As Principal Statistician at Orphazyme you will become part of a rapidly growing biotech company that is about to hand in their first NDA submission and aims for the commercialization phase at the end of next year.
You will be responsible for statistical/strategic input to the clinical development plans while supporting clinical trials within a program. You will be key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community will also be your responsibility.
Among others your main tasks are:
You have min. 10 years of experience with statistics from the pharmaceutical industry taking a drug from preclinical phase to launch. You have experience with submission activities, MMA and NDA and are used to synthesizing data in order to provide relevant input to stakeholders. You have knowledge of FDA regulations, ICH GCP guidelines and the drug development process. Furthermore, you have experience with SAS and knowledge of CDISC standards. Your educational background is a Master’s Degree in Statistics, Mathematics or the like. A Ph.D is prefred but not required.
You are a person with excellent collaboration and communication skills. You thrive in a dynamic and entrepreneurial research environmet and are open to challenges and working in a proactive way.
Orphazyme offers a unique opportunity of joining a dedicated team and company. You will become an important part of an exciting journey in a progressive and innovative biopharmaceutical company. Orphazyme has a flat organizational structure and they offer a good, flexible and humoristic working environment.
For more details about the job or the company, please contact Senior Research Consultant Ane Møller Sørensen, Unique Human Capital on email@example.com. All applications must be in English and are treated confidentially.