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Senior Biostatistics Director
2 months ago
We are seeking a highly skilled and experienced Senior Biostatistics Director to join our team at Genmab. As a key member of our Biostatistics and Data Science department, you will play a critical role in supporting the clinical development of our compounds and indications.
Key Responsibilities- Compound/Indication Level
- 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
- Acts as a role model
- Ensures consistency of statistical methods and data handling across trials
- Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
- Supports compound responsible programmer in developing an integrated database specification
- Trial Level
- Represent Genmab during meetings/congresses and courses and perform professional networking
- Engage with regulatory authorities on trial level discussions
- Arranges/attends lessons learned to share takeaways
- Represents Genmab during Key Opinion Leaders meetings
- Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
- Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
- Ensures groundbreaking statistical work which includes but is not limited to:
- Applying adequate methods for which a solid scientific foundation exists
- Ensure proper documentation of work done
- Keep oversight and QC essential documents/data provided by vendors
- Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
- Master's or PhD in a statistical field with 8+ (AD) and 12+ years (Director) 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 in advising multiple complex projects/studies in a technical capacity
- Experience leading and mentoring teams (Director)
- Confirmed performance in earlier role/comparable role
