Genmab
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.
Associate Director, Biostatistics
April 2
Genmab
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
• The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs. • Contribute to clinical development strategies and plans. • Engage with regulatory authorities on compound/indication level discussions. • Ensure consistency of statistical methods and data handling across trials. • Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques. • Support timely delivery of statistical deliverables and ensure proper documentation of work done.
🎯 Requirements
• Master's or PhD in a statistical discipline with 8+ of experience in relevant technical area. • 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
• Regular full-time U.S. employees are eligible to enroll in Genmab benefits. • Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.
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