Senior Biostatistics Leader, Clinical Development

Avalo Therapeutics, Inc.

Northern (KY)

Hybrid

USD 140,000 - 190,000

Full time

26 hours ago

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Job summary

Avalo Therapeutics is seeking a Sr Manager/Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs. You will lead statistical strategy for multiple programs and partner with Clinical Development, Medical Affairs, Data Management, and Regulatory Affairs to ensure high-quality analyses and regulatory submissions.

The role offers opportunities to influence development strategy, advance innovative methods, and contribute to

Qualifications

Ph.D. or M.S. with substantial pharmaceutical/clinical research experience.
Experience leading clinical development programs and trials.
Strong regulatory submission experience and health authority interactions.

Responsibilities

Lead the biostatistics strategy for one or more clinical development programs.
Serve as statistical representative on cross-functional study teams and governance committees.
Collaborate with clinical teams on study design, endpoints, and sample size.
Develop and review SAPs, TLFs, and study reports with regulatory compliance.
Interact with FDA/EMA/other authorities and support regulatory submissions.
Oversee CROs and external vendors to ensure timely, high-quality deliverables.