Biostatistics Director – Indication Lead, Myasthenia Gravis

🕒 Fevereiro 10

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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argenx

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2008

🧬 Biotecnologia

Biotechnology

A argenx é uma empresa de biotecnologia comprometida em melhorar a vida dos pacientes por meio de inovação em imunologia. A empresa concentra-se no desenvolvimento de terapias inovadoras baseadas em anticorpos para tratar doenças autoimunes graves. Adotando uma abordagem colaborativa com cientistas pioneiros e parceiros acadêmicos, a argenx acelera a descoberta de anticorpos terapêuticos que têm como alvo vias específicas das doenças. Os produtos proprietários da empresa, como o efgartigimod, têm como objetivo tratar doenças em que os anticorpos IgG são patogênicos. A argenx enfatiza a inovação, a ciência da colaboração e abordagens centradas no paciente em sua missão de oferecer soluções médicas transformadoras.

Descrição

• Serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets) • Drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for • Drive quantitative data strategy of the indication you are responsible for • Collaborate with stakeholders and lead delivery of all statistical deliverables • Oversee delivery of all statistical deliverables for the indication you are responsible for and contribute to HA submissions • Report to a franchise team leader, within the Biostatistics and Modeling organization • Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements • Guide the team of statisticians supporting the different assets

🎯 Requisitos

• Master or doctorate (Ph.D.) degree in Statistics or related field • At least 7 years of experience in biotech/pharma industry • Proven record of leading statistical activities, including dossier submission and major agency interactions involving BLA/NDA/MAA (pre and post dossier submission) • Expertise in drug development • Experience driving complex innovative designs or cutting-edge methods • Advanced knowledge of biostatistics and a strong command of its application to clinical trials • Proficient in statistical software (SAS and/or R) • Ability to collaborate with program partners and stakeholders to deliver on the statistical deliverables • Ability to clearly explain complex statistical concepts in written and spoken English • Team player with a focused attitude • Ability to work autonomously as part of a cross-disciplinary team in a dynamic environment of a fast-growing biotech company with challenging timelines • Ability to motivate and empower statisticians supporting you

🏖️ Benefícios

• Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies • A work-environment in a human-sized, dynamic, rapidly growing biotech company • Competitive salary with extensive benefits • Chance to grow and be a part of a team driven by creativity, innovation and science • Eligibility to participate in short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies • Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines