Jobs at Biogen

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

The Associate Scientific Director will lead pharmacometrics analyses, contribute to drug development strategies, mentor colleagues, and support decision-making through advanced quantitative modeling.

Lead and oversee clinical monitoring for assigned studies, managing Site Managers and CRAs to ensure ICH-GCP compliance, data integrity, TMF completeness, inspection readiness, risk-based monitoring consistency, and issue resolution. Mentor and train monitoring staff, partner with QA and stakeholders, track site performance and enrollment, and contribute to clinical tool and process development.

Lead clinical development activities for early-phase neuroimmunology programs (I-II). Design protocols, provide medical monitoring, oversee study execution, collaborate cross-functionally and with CROs, support regulatory interactions, interpret data, and incorporate patient-centered approaches to advance immunology drug candidates.

Oversee clinical pharmacology plans for drug candidates, lead studies, analyze pharmacokinetic data, and engage with health authorities to guide drug development strategies.

Lead the Informed Consent Management (ICM) function supporting study start-up and maintenance for global clinical trials. Triage ICF requests, advise on IRB/EC changes, author Global Master ICFs, oversee CRO consent activities, monitor compliance and KPIs, produce metrics, and drive process improvements and SOP/Work Instruction maintenance to ensure timely, high-quality informed consent documentation.

Lead end-to-end in-house site feasibility for clinical trials, manage cross-functional stakeholders, run outreach via site questionnaires, perform data-driven feasibility analyses and site ranking, create visualizations and reports, maintain feasibility databases, and support scenario modeling for trial operational designs.

Own and administer Biogen's Small Business Subcontracting Plan (SBSP), ensure federal compliance and audit readiness, maintain supplier diversity data, integrate ESG/diversity into sourcing decisions, support sourcing teams, perform spend analytics, produce government and ESG reports, and represent the company in supplier diversity networks.