Senior Biostatistics Director

4 weeks ago


King of Prussia, Pennsylvania, United States Aequor Technologies Full time
Job Summary

As a Senior Biostatistics Director at Aequor Technologies, you will lead late phase project and regulatory submissions, representing Biostatistics in interactions with regulatory authorities. You will define statistical strategy and ensure appropriate statistical methodologies are applied to study design and analysis for clinical trials.

Key Responsibilities

Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and analysis for clinical trials.
Represent Biostatistics in interactions with regulatory authorities, such as the FDA, EMA, and PMDA.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
Influence and contribute to clinical development plans, collaborating with cross-functional teams for governance reviews.
Lead statistical strategy for planning and study execution, and quantitative evaluation of clinical trials, regulatory submissions, and related documents.
Ensure timeliness and quality of deliverables by CRO/FSP, and manage outsourcing operations or work with internal statistical programmers within the responsible program.

Qualifications

Ph.D. with 8 years of experience or MS with 11 years of drug development experience.
Experience with adaptive design, interaction with Regulatory Affairs, and hands-on skills in programming.
Ability to think strategically and effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.

What We Offer

Aequor Technologies offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to delivering high-quality results and making a meaningful impact in the field of biostatistics.

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