Senior Director - Biostatistics

July 25

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Dianthus Therapeutics, Inc.

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Unlocking the full potential of complement therapeutics through the power of selectivity.

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💰 $100M Private Equity Round on 2022-04

Description

• As the Senior Director, Biostatistics you will be responsible for developing and executing on our biostatistics strategy, directly impacting overall success of our clinical programs. • Reporting to the Senior Vice President, Clinical Development, you will execute and oversee modelling and simulation activities in support of the clinical trial designs. • You will work closely with internal external partners to help make decisions both operationally and strategically, that impact statistical aspects of clinical development plans of one or more compound/programs. • You will participate in meetings with diverse regulatory authorities (FDA, EMA, PEI), assess potential CROs and their proposals from a stats perspective, maintain oversight and provide strategic input on CRO collaboration and/or stats vendors. • Experience with IND SAP for Phase II and III, working with and responding to regulatory agencies, and experience with interim analysis are also required. • This is a great opportunity for an experienced Biostatistics leader to join a growing organization and have significant impact.

Requirements

• PhD or masters in Biostatistics or equivalent degree • Expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices. • Fluent with other statistical software such as R, EAST, Winbugs is a plus. • Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials. • Displays excellent communication skills with demonstrated leadership ability. • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study. • Experience in managing Biostatics vendors • Auto-immune and/or neurology clinical study background is a plus • Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision • Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision • Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable • Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions