Associate Director, Biostats

Job not on LinkedIn

🕒 January 10

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $146.6k - $220k / year

⏰ Full Time

🟠 Senior

👔 Director

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Genmab

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

🧬 Biotechnology

💰 $134M Post-IPO Equity on 2010-06

Biotechnology

Genmab is a biotechnology company focused on transforming lives through pioneering antibody science. The company is dedicated to developing innovative antibody therapeutics for various diseases, aiming to improve patient outcomes and treatment options. Genmab's efforts in antibody research and development highlight its commitment to advancing medical science.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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