Senior Manager - Biostatistics

About the Department
As a part of Novo Nordisk's Strategy and Rare Disease organization, the Forma team is focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Its R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Forma's Pharm Sci and QA team is focused on activities supporting clinical supply chain, drug formulation & manufacturing, and GMP, GCP, auditing in support of Sickle Cell Disease (SCD) programs. We're looking for individuals who are enterprise thinkers, inclusive leaders, and strong collaborators, as we embark on shaping our future. Are you ready to make a difference?
The Position
Novo Nordisk is expanding its presence in the Boston area with a focus in rare diseases with unmet need. The Biostatistician position will be part of the Data Science organization. This position will work in the rare disease area, with potential indications such as sickle cell disease, thalassemia, and other disorders involving red blood cell health. This development program has the potential to serve patients who have huge unmet need, creating a meaningful impact in their daily lives.
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?
Reporting to the Director of Biostatistics, the successful candidate will provide input on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The candidate will contribute to biostatistically focused regulatory interactions and submissions to the FDA and other regulatory agencies.
Relationship
Interacts extensively with study medical lead, data manager, trial manager, and SAS programmer(s). Consults with biostatistical colleagues located both in the US and in Denmark.
Reports to Director of Biostatistics. No direct reports.
Essential Functions

• Contribute to study level tasks from a 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
• Oversee statistical work by contract research organization (CRO) and ensure quality deliverables with respect to key performance indicators, metrics, and program level deliverables and timelines
• Collaborative with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Independently conduct analyses suggested by the data
• 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

Physical Requirements
Up to 10% overnight travel required.
Qualifications

• Master's degree with minimum of 6 years OR PhD with a minimum of 4 years relevant experience
  • Preferred degree discipline in Statistics, Biostatistics or Mathematics
• Relevant experience includes:
  • Management of multiple projects and studies and being able to prioritize
  • Experienced in study level work including authoring SAP and TFL specification
  • Development of SAS programs to perform planned or ad hoc analyses and prepare data displays
  • Solid SAS programming skills for QC of data analyses or derivations
  • Experience following standard operating procedures
  • Experience working in the clinical trials setting within the pharmaceutical sector
  • Familiar with GCP, ICH guidelines, FDA/EMA/other regulatory authority guidance
  • Strong communication and interpersonal abilities, adept at translating complex statistical ideas into actionable project strategies.
  • Problem-solving skills and a proven track record of efficiently managing multiple tasks in alignment with company timelines.
• Preferred experience:
  • Knowledge of CDISC standards including SDTM, ADaM, and controlled terminologies
  • Working understanding of mathematical and statistical principles; Experience in broad statistical methods (eg. longitudinal data analyses, Bayesian methods, adaptive design)

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.