Principal Statistician at Orphazyme

31. juli, 2020

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:

  • Overall accountability for setting up, overseeing and directing all statistical activities and deliverables
  • Provide input to Drug Development and Clinical Development Plans
  • Provide input to the strategy for Biometrics in alignment with the company strategy
  • Contribute to design of Clinical Development Programs and Clinical Trials in collaboration with Clinical Science department
  • Provide oversight of biometrics deliverables when outsourced to CROs
  • Execute the strategy on time and with expected quality
  • Represent Orphazyme’s statistical position to regulatory agencies
  • Ensure adherence to regulatory and company standards, including estimand definitions
  • Key contributor in project planning
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
  • Become knowledgeable within disease areas under study (e.g. available treatments, course of disease, endpoints, and analyses used for previous submissions)
  • Develop and assist with maintenance of department tools, templates, guidelines, SOPs, and systems.

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.

Travelling: Limited

Domicile: Copenhagen

For more details about the job or the company, please contact Senior Research Consultant Ane Møller Sørensen, Unique Human Capital on M: +45 24 45 25 84. All applications must be in English and are treated confidentially.

Apply job here.

Orphazyme is a Danish biopharmaceutical company with a late-stage drug pipeline, developing new treatment options for orphan protein-misfolding diseases. Orphazyme develops new therapies that mobilize a group of stress-response proteins, called heat-shock proteins. Heat-shock proteins help restore balance to cells affected by stress arising from misfolded proteins, protein aggregates, and lysosomal dysfunction. Orphazyme’s pipeline comprises three potential registration studies, with the first potential marketing authorization expected in 2021.