Associate Director, Biostatistics

About the role

The Associate Director supports the clinical development of compounds and indications, providing statistical expertise and contributing to clinical development strategies and plans.

Responsibilities

• 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
• Engage with regulatory authorities on compound/indication level discussions
• Represent Genmab during meetings/congresses and courses and perform professional networking
• Represent Genmab during Key Opinion Leaders meetings
• Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager
• Ensure state of the art statistical work which includes but is not limited to: Applying adequate methods for which a solid scientific foundation exists, ensuring proper documentation of work done, keeping oversight and QC essential documents/data provided by vendors, ensuring trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
• Participate in definition, review, and approval of data packages for Data Monitoring Committees
• Support regulatory submission/filing activities

Qualifications

• 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 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

Skills

• Genuinely passionate about Genmab's purpose
• Precision and excellence in all work
• Belief in Genmab's rooted-in-science approach to problem-solving
• Generous collaboration with a broad spectrum of backgrounds
• Enabling the best work of others on the team
• Grappling with the unknown and innovating
• Experience working in a fast-growing, dynamic company
• Hard work and enjoyment of the work

Benefits

Genmab supports physical, financial, social, and emotional wellness. Eligible for 401(k) plan, health benefits, and additional perks.

Pay

$156,880.00—$235,320.00

Schedule

Flexible working hours to support work-life balance.