About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?

The Position

Reporting to the Executive Director of Biostatistics and Programming, the Director of Biostatistics acts as statistical lead across all of Dicerna's drug development programs. 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. The person will participate in the development and implementation departmental standards, applications, processes, and training.

Relationships

The Director of Biostatistics will report to the Executive Director of 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 analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Lead in developing department standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications
• Contribute to project budget/resource planning, re-forecasting, and program milestones
• Develop SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays

Physical Requirements

0-10% overnight travel required.

Qualifications

• PhD in Statistics, Biostatistics or Mathematics with a minimum 7-10 years’ experience (or MS with minimum 10 years’ experience) 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 specification
• Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies
• Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance
• Solid understanding of mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, adaptive design) is preferred
• Detailed-oriented with organization, problem-solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
• Familiar with SAS and/or R; knowledge and experience in CDISC requirements including SDTM, ADaM, and controlled terminologies

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.