Director, Biostatistics

4 days ago

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Genmab

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1001 - 5000

💰 $134M Post-IPO Equity on 2010-06

Description

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

Requirements

• Master's or PhD in a statistical discipline with 12+ years 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 • Experience leading and mentoring teams • Proven performance in earlier role/comparable role