Nykode Therapeutics AS

Are you interested in joining a Scandinavian biotech company? Our bold aim is to generate game-changing therapeutics to treat cancers and infectious diseases with a high unmet medical need. With our unique and innovative modular vaccine technology, we’re specifically targeting antigens to Antigen Presenting Cells, which are essential for inducing rapid, strong and long-lasting immune responses.

About the role

We have a very exciting position for an additional Biostatistician to join us, in either Oslo or Lyngby - being overall accountabe for providing statistical input to clinical development plans, trial designs, clinical trial synopses and protocols, Health Authority documents and publications.

As Biostatistician, you will act as the in-house expert with respect to all statistical tasks and elements across the assigned development projects in Nykode. The role is a key member of cross-functional project teams and serves as an ad-hoc member in clinical trial teams. The role is expected to participate actively in various internal process optimization initiatives related to statistical tasks, programming and data management. You will report to Head of Development Operations.

Main job tasks and responsibilities:

• Provide statistical input to clinical development plans, clinical trial synopses and clinical trial protocols
• Provide input to and review of CRO proposals for new trials
• Contribute to Health Authority interactions/meetings and provide relevant input to Health Authority documents as well as publications
• Participate in CRO meetings and interactions, review Statistical Analysis Plans and other relevant trial specific documents and plans
• Oversigth of clinical trial data analysis made by CRO counterparts
• Provide input to clinical trial protocols and reports
  
• Serve as subject matter expert on all aspects of biostatistics, having profound knowledge of industry standards, regulations and processes
• Ensure adherence to GCP, statistical principles, SOPs and external guidelines
  

Who are we looking for?

When hiring new employees, we look for the people who are inspired by the Nykode technology and our quest to unlock the future of medicine. We are eager to hire those who seek out environments that offer creative challenges and provide growth opportunities. If you feel at home in a highly collaborative, flexible, and courageous company culture, Nykode might be the right place for you. 

For this role, we are seeking an individual who brings expert knowledge of statistical methodologies related to trial design, execution and reporting within early phase oncology and infectious disease clinical trials/vaccine trials. Furthermore, the person has acquired a solid understanding of GCP and statistical regulatory guidelines and framework from previous roles, as well as experience from clinical trial setup, conduct and closure. Being skilled in SAS programming and having knowledge of ADAM/SDTM standards, as well as extensive experience from CRO oversight activities related to statistical deliverables and metrics is essential. As the Biostatistician will work closely with cross-functional project teams, having strong interpersonal skills and being a good communicator is key in driving development projects forward together with the team.

Education and experience:

• University degree in statistics, life science, computer science or equivalent
• Minimum 5 years of pharma/biotech/CRO experience within drug development / biostatistics / data science
• Programming experience and expertise in statistical software (SAS)
• English fluency is required (both written and oral)

The application process

Applications will be reviewed on a rolling basis with a deadline on 31st of May 2022.

 

We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@nykode.com