Associate Director, Biostats

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🕒 Janeiro 10

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $146.640 - $219.960 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Genmab

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1999

🧬 Biotecnologia

💰 $134.000.000 Post-IPO Equity em 2010-06

Biotechnology

Genmab é uma empresa de biotecnologia focada em transformar vidas por meio da ciência pioneira de anticorpos. A empresa é dedicada ao desenvolvimento de terapias inovadoras com anticorpos para diversas doenças, com o objetivo de melhorar os resultados dos pacientes e as opções de tratamento. Os esforços da Genmab em pesquisa e desenvolvimento de anticorpos destacam seu compromisso em avançar na ciência médica.

Descrição

• Act as lead and main point of contact related to Statistics for designated compound/indication • Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies • Engage with regulatory authorities on compound/indication level discussions • Ensure consistency of statistical methods and data handling across trials • Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor • Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques • Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable • Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs • Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles • Engage with regulatory authorities on trial level discussions • Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable

🎯 Requisitos

• Master's or PhD in a statistical discipline • 8+ years of experience in relevant area preferred, or demonstrated capability • Experience in statistical analysis, modelling and simulation and adaptive trial designs • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics • Experience with the relevant regulatory requirements for biostatistics processes and SOPs • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions • Experience directing multiple complex projects/studies in a technical capacity • Proven performance in earlier role/comparable role

🏖️ Benefícios

• 401(k) Plan: 100% match on the first 6% of contributions • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses