Associate Director - Biostatistics

About the Department
At Novo Nordisk Research Center Seattle, Inc. (NNRCSI) our scientists apply cutting-edge technologies to early R&D projects with the goal of bringing real change to people with Diabetes and Obesity. Our scientists apply state-of-the-art technologies within the diabetes and obesity areas, with the goal of bringing molecules to market. Your skills, dedication and ambition will help change lives for the better and you will work with extraordinary talent, continuously learn and develop, and drive changes to defeat serious chronic conditions. We recognize the importance of an enjoyable workplace, which stimulates a strong culture of ingenuity and innovation and our support of a healthy work-life balance adds to a best-in-class employee experience. The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop in their careers. You'll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we've cultivated a culture of fun, ingenuity and innovation. We are changing lives, are you ready to make a difference?
The Position
Key responsibilities for Associate Director of Biostatistics are: Driving the statistical strategy of the designated projects taking into consideration the impact across Development. Responsible for shaping and driving the statistical content and quality of deliverables for submissions and authority interactions. Responsible for ensuring consistency and relevant standardization within the designated projects on statistical activities based on a thorough analysis and interpretation of internal and external factors. Being a role model as statistical expert, serving as mentor and inspiration for the team.
Relationships
This position will report to the Executive Director of Biostatistics and Programming.
Essential Functions

• Driving the statistical strategy of the designated projects taking into consideration the impact across Development
  • Instrumental in planning the development of a drug, designing clinical trials and interpreting the results of the clinical trials carried out in the project
  • Provide key input to post approval marketing communication
  • Lead project teams to achieve milestones and objectives
  • Prioritize, plan, manage and execute clinical trials and submissions within project area
  • Proactively looks for opportunities where new methodology and processes could save costs and time and increase quality
  • Acts independently as consultant on statistical aspects in complex and high-profile problems
  • Drives knowledge sharing also across project areas
• Responsible for shaping and driving the statistical content and quality of deliverables for submissions and authority interactions
  • Presentation and negotiation of clinical development program at meetings with regulatory authorities, first submission incl. FDA AdCom meetings
  • Ensure the right quality level of statistical deliverables for regulatory documents and interactions, e.g. summary documents, Q&A, AdComm etc, considering risk willingness
  • Represents Novo Nordisk regarding statistics in meetings and inspections with regulatory authorities

• Responsible for ensuring consistency and relevant standardisation within the designated projects on statistical activities based on a thorough analysis and interpretation of internal and external factors
  • Ensure development of standards on the project, e.g. Project ADRG and statistical methodologies
  • Develops and makes available the best statistical methods and techniques
  • Challenge status quo and seek out new innovative tools or ways of working to simplify processes and enhance Biostatistics impact
  • Further expand competences and know-how within statistics
• Being a role model as statistical expert, serving as mentor and inspiration for the team
  • Inspire and motivate team, and ensure excellent deliverables by self and team
  • Act as a resource for colleagues with less experience, e.g. by training and mentoring staff within the project
  • Perceived as an expert within key Biostatistics processes, and must ensure to keep specialist knowledge up to date

Physical Requirements
UP to 10% overnight travel required.
Qualifications

• Master's degree in Statistics or Biostatistics with 7+ years of experience, or Ph.D. with 5+ years of experience.
  • Experience as a statistician within the pharmaceutical industry or equivalent required
• Expert knowledge of biostatistical methods
• Extensive and broad experience with practical applications of biostatistical methodology
• Knowledge specialist of drug development
• Broad experience with statistical software and IT and in-depth experience with at least one statistical software package
• In-depth knowledge of GCP and statistical guidelines within drug development
• Extensive experience with communication and presentation of statistical issues
• Elevated business insight to proactively deliver required results of key value to stakeholders with a focus on how stakeholders depend on the deliverables
• Regular participation in medical and statistical conferences/ workshops
• Experience with supervision and mentoring of staff
• Experience with the process of drug applications with the FDA, PMDA and EMA
• Extensive experience with collaboration across professional and regional borders
• Consultancy experience within a broad area of clinical and/or non-clinical R&D
• Record of presentations/ publications
• Interaction with external contacts in the pharmaceutical industry and in academia

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.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.