Director - Biostatistics

About the Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
Reporting to the Executive Director of Biostatistics and Programming. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The person will lead and oversee biometric focused regulatory interactions and submissions to the FDA and other regulatory agencies; Additional mentoring and delegation of tasks will be required as appropriate.
Relationships
The Director of Biostatistics will report to the Executive Director - Biostatistics and Programming
Essential Functions

• Contribute in study level tasks from statistics perspective, including but not limiting to: study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
• Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from the statistics perspective
• Work collaboratively with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Oversee statistical work by CRO and ensure quality deliverables with respect to key performance indicators, metrics, and program level deliverables and timelines
• Translate statistical thinking into a strategic input to advance the clinical program
• Independently conduct complex statistical analyses
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Author/review regulatory documents or scientific publications
• Contribute to project budget/resource planning, re-forecasting, and program milestones
• Effectively communicate and collaborate across global sites and sets project strategy by providing leadership of cross-functional project teams.

Physical Requirements
Up to 10% overnight travel required. This position may be based in either Lexington, MA or Plainsboro, NJ.
Qualifications

• PhD in Statistics, Biostatistics or Mathematics with a minimum 7 years' relevant experience; MS (minimum degree required) with 10 years' experience may also be considered
  • Preferred that experience is majority gained from working in the pharmaceutical/biotech/device industry
• Led in NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
• Strong ability to prioritize tasks to statistical and programming resources
• Adept at outsourcing and managing biostatistical services provided by CRO's and contractors
• Experienced as product lead statistician and contribute to strategy discussion in cross-functional settings; Experienced in managing multiple products and studies and being able to prioritize
• Experienced in study level work including authoring SAP and TFL shells
• Develop SAS/R programs as necessary to perform planned or ad hoc analyses
• Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies; with an emphasis on presentation abilities

• In-depth knowledge of GCP and statistical guidelines within drug development
• Extensive experience with communication and presentation of statistical issues
• Solid understanding of mathematical and statistical principles, expert knowledge of biostatistical methods
• Detailed-oriented with organization, problem-solving and prioritization skills
• Experience with supervision and mentoring of staff
• Experience with the process of drug applications with the FDA, PMDA and EMA
• Experience in the MASH therapeutic area is preferred

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.