Biostatistics Outsourcing Specialist

Do you have experience in working with clinical trial programming and a firm knowledge of clinical drug development? And do you have a strategic mindset and strong communication skills as well as an interest in working with suppliers within Biostatistics?

You might be the one we are looking for to be part of driving the outsourcing of Biostatistics deliverables in clinical studies. Apply today and join us for a life-changing career!

The Position
Novo Nordisk is looking for a highly motivated professional to join our Biostatistical oversight team as a Biostatistical Outsourcing Specialist. As a member of our team, you will play a critical role in coordinating our efforts in ensuring the quality, accuracy, and integrity of our outsourced clinical trial data. Working closely with our vendors and the therapy projects to ensure that all regulatory and Biostatistical requirements are met.
 

As a Biostatistics Outsourcing Specialist, you will have the opportunity to:

• Work closely with our vendors and the therapy projects to ensure that all regulatory and Biostatistical requirements are met.
• Set a direction for how the clinical oversight of the biostatistical deliverables will be performed, developing innovative approaches, tools, and presentations of the trials data across many outsourced trials, ensure that appropriate oversight is maintained throughout the trial conduct. Collaborate closely with our data science teams and other stakeholders to ensure that all vendor data deliverables meet Novo standards and are conducted in an efficient, effective, and ethical manner.
• Collaborate closely with internal stakeholders to define project requirements, timelines, and deliverables.
• Together with the Biostatistics oversight team, ensure compliance with regulatory requirements, internal quality processes, and industry standards.
• Identify and mitigate risks associated with outsourcing biostatistical services and provide regular updates to Biostatistics management on vendor performance and projects status.
   

Qualifications
We realise that few people are experts at everything. But if you can nod your head at some of the following attributes then you could be the person, we are looking for:

• M.Sc., PhD.  degree in Natural or Technical Sciences (or equivalent theoretical background – please qualify in application)
• 5 years of experience within clinical development within biostatistics, ideally with a focus on clinical trial outsourcing
• Expert programmer within SAS, R and/or Python
• Strong knowledge of regulatory requirements related to the conduct of clinical trials and data deliverables.
• Excellent communication and collaboration skills, with the ability to work closely with vendors, data science team members, and other stakeholders
• Strong problem-solving and critical thinking skills, with the ability to drive decision making and identify areas for improvement

About the department
In the Novo Nordisk Development function, we are responsible for managing clinical drug development worldwide, ensuring that our processes follow global standards, regulations and business ethics while still delivering viable and innovative medicine. 

We are a strategic function to the Data Science organisation. We provide strategic support and part of driving cross functional strategic initiatives. The team consist of engaged self-driven experts with a diversity of scientific backgrounds, such as data science and statistics, programming and in-depth knowledge across Biostatistics and Data Management processes, innovation, automation, digitalization tools and strategy development.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to improve the lives of patients.

Contact
For more information, please reach out to Senior Director Shakeel Dar at [email protected] or Outsourcing Project Director Sajel Howlett at [email protected].

Deadline
19 May 2024

We will process applications as we receive them, so please apply as soon as you can.

There is no requirement to append a cover letter with your application. However, we would appreciate if you could incorporate a brief statement in your resume or CV detailing your motivation for applying. In the interest of promoting an efficient and equitable recruitment process, we kindly request you to exclude any photographs from your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.