Jobs at Biogen

Leads biostatistical support for late-stage and early-development clinical programs, including study design, protocol development, statistical analysis plans, modeling, simulations, data analysis, and clinical study reports. Collaborates with cross-functional teams, programmers, data management, vendors, and regulatory personnel. Provides statistical expertise for submissions and legal matters, improves processes, mentors junior statisticians, and supervises assigned FSP statisticians.

Leads end-to-end clinical biomarker strategy development and implementation for immunology and neuromuscular clinical programs, including pivotal studies. Oversees biomarker data generation, analysis, interpretation, assay development, outsourced projects, and cross-functional collaboration. Provides scientific mentorship, supports clinical trial and regulatory documentation, manages external partnerships, and engages regulators and industry stakeholders through presentations, publications, and consortia.

Leads biostatistical strategy and deliverables for late-stage nephrology clinical development projects. Oversees clinical trial design, analyses, regulatory submissions, and evidence generation while ensuring scientific rigor and regulatory compliance. Supervises, coaches, and mentors statisticians; represents biostatistics on cross-functional teams, governance committees, regulatory interactions, and advisory boards. Drives statistical innovation, process improvement, stakeholder collaboration, and departmental capability development.

Leads immunology drug discovery and external innovation efforts for immune-mediated and inflammatory diseases. Evaluates targets, mechanisms, biomarkers, technologies, external assets, and collaborations; supports scientific due diligence and portfolio strategy. Guides in vitro, ex vivo, and in vivo research, integrates translational and disease-relevant data, and communicates recommendations to senior stakeholders. Partners across research, development, business development, strategy, and external organizations while mentoring scientists and contributing to collaborative team leadership.

Lead biologics discovery efforts, manage and grow a scientific team, drive antibody engineering and molecular design strategies, partner cross-functionally to advance discovery programs, evaluate external innovations, and support candidate selection and translational assessments.

Leads end-to-end clinical trial operations, including study strategy, protocol development, CRO oversight, risk mitigation, quality, timelines, budgets, and compliant execution. Chairs study management teams and coordinates cross-functional drug development activities across neurological and nephrology programs. Requires strong clinical operations leadership, GCP and ICH expertise, CRO management, project management, and scientific knowledge.

Provides strategic clinical quality and compliance leadership across R&D, including QMS governance, clinical study oversight, risk management, investigations, CAPA, vendor quality governance, audits, regulatory inspections, and continuous improvement. Advises cross-functional teams on GCP and global regulatory requirements while strengthening inspection readiness, data integrity, patient safety, and quality performance.

Supports early-phase immunology and neuroimmunology clinical development programs, including protocol design, trial execution, medical monitoring, data interpretation, regulatory interactions, safety planning, and clinical documentation. Partners with cross-functional R&D teams, CROs, investigators, and external stakeholders while providing therapeutic expertise and monitoring developments in autoimmune disease.

Leads observational epidemiology research, including cohort, registry-based, and database studies, supporting disease understanding and post-market safety. Reviews epidemiological literature, estimates disease incidence, prevalence, progression, and risk factors, and contributes to regulatory activities such as safety reports, pharmacovigilance, and risk management plans. Collaborates cross-functionally on evidence-generation planning and delivers epidemiologic expertise for clinical development, safety, medical, and value-access decisions.

Leads enterprise architecture for Biogen’s Veeva ecosystem across Development, Quality, Regulatory, Safety, and Commercial functions. Translates business needs into scalable Veeva configurations and integrations, governs target-state architecture and platform standards, reviews solution designs, and oversees implementation and release planning. Mentors configuration teams, drives cross-vault consistency, manages architecture governance, aligns with Veeva product roadmaps, and advises IT leadership on platform strategy, investments, regulatory compliance, and business objectives.

Leads the architecture, implementation, and governance of enterprise IAM and IGA solutions using SailPoint and ServiceNow. Designs integrations, provisioning workflows, access certifications, role management, and segregation-of-duties controls across enterprise systems. Provides technical leadership, conducts design reviews, mentors IAM teams, leads workshops, manages risks, and ensures GxP, SOX, security, compliance, and audit requirements are met.

Lead biostatistical efforts in clinical research, oversee analysis plans, mentor junior staff, and ensure statistical integrity. Key role in data analysis and regulatory submissions.

Support the Country and Site Lead by providing local operational and scientific expertise to inform clinical development strategy. Act as single point of contact for CROs, affiliates, and global teams; drive site engagement, monitor country performance (KPIs), support site selection, resolve investigator/site issues, and oversee sponsor oversight activities. Field-based role with heavy travel to enable trial delivery and quality.