5 sr full stack developer jobs found

Biogen About This Role The National Director will help to develop, maintain, and execute a US thought-leadership engagement plan and professional education program for a late-stage Nephrology asset, starting with post-transplant Antibody Mediated Rejection (AMR) and Microvasculature Inflammation (MVI), over time progressing to include IgA Nephropathy and other renal conditions as the asset continues to develop, We are seeking an individual who can establish and execute a strategy to engage Thought Leaders, develop advocacy, capture market insights, and liaise with marketing on key initiatives. Starting off in an individual capacity, the role will evolve to oversee a team of Thought Leader Liaisons (TLLs). This role will report to the US Nephrology Marketing Lead and be a core part of the Nephrology Marketing Leadership as well as the US Launch Operating Team. The individual will work closely with their marketing and insights colleagues as well as sales, family access,...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen About This Role: As the Sr. Medical Director specializing in Multiple Sclerosis and Immunology, you will be a pivotal member of our Clinical Development team. This role integrates scientific rationale, regulatory requirements, product development plans, and commercial goals to construct a strategic framework for our clinical development initiatives. You'll be responsible for developing and implementing the Clinical Development Plan (CDP) for both our clinical development pipeline and research assets. Leading and overseeing the clinical development of early clinical stage assets through to registration and post-approval is a core aspect of this position. You will provide critical clinical insights for early development assets, working alongside our research function. Your expertise will also be crucial in partnerships and in-licensing activities, where you will offer clinical input and participate in due diligence for potential external assets. This role not only...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...