Director, Biostatistics

4 days ago

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Logo of Genmab

Genmab

1001 - 5000

πŸ’° $134M Post-IPO Equity on 2010-06

Description

β€’ The Director acts as a statistical expert supporting the clinical development of compounds β€’ Contributes to clinical development strategies and plans β€’ Acts as lead and main point of contact related to Statistics β€’ Ensures consistency of statistical methods and data handling across trials β€’ Supports compound responsible programmer in developing an integrated database specification β€’ Provides scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques β€’ Represents the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/ or Partner meetings β€’ Ensures availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions β€’ Engages with regulatory authorities on compound/indication level discussions

Requirements

β€’ Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical area β€’ Experience in statistical analysis, modelling and simulation and adaptive trial designs β€’ Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred β€’ Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics β€’ Experience with the relevant regulatory requirements for biostatistics processes and SOPs β€’ Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies β€’ Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions β€’ Experience directing multiple complex projects/studies in a technical capacity β€’ Experience leading and mentoring teams β€’ Proven performance in earlier role/comparable role

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