dt~4mo ago

Senior Director, Biostatistics (Boston, MA)

senior

OtherDirector

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Quick Summary

Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Senior Director, Biostatistics (Boston, MA)…

Key Responsibilities

Build, mentor, and lead a high-performing statistical team, fostering collaboration, learning, and accountability. Provide strategic and statistical leadership as a core member of the clinical development team, collaborating with cross-functional…

Requirements Summary

Ph.D. in Biostatistics or Statistics with 10+ years of industry experience, or Master’s degree with 12+ years of experience. Proven expertise in statistical activities for clinical development programs, including successful regulatory submissions…

Technical Tools

OtherDirector

Responsibilities

~1 min read

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Build, mentor, and lead a high-performing statistical team, fostering collaboration, learning, and accountability.
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Provide strategic and statistical leadership as a core member of the clinical development team, collaborating with cross-functional stakeholders.
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Partner with medical, regulatory, pharmacology, clinical operations, and other functions to implement appropriate statistical methodologies and analysis plans.
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Champion innovative statistical approaches, such as adaptive, seamless, and Bayesian designs, to enhance trial efficiency and success rates.
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Ensure the accuracy, integrity, and consistency of statistical analyses across clinical development programs, from Phase I through regulatory submissions and post-approval activities.
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Contribute to the development and implementation of Standard Operating Procedures (SOPs) and workflows, ensuring regulatory compliance and adherence to industry best practices.
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Oversee CRO activities, ensuring high-quality deliverables, adherence to timelines, and efficient use of resources.

Requirements

~1 min read

Ph.D. in Biostatistics or Statistics with 10+ years of industry experience, or Master’s degree with 12+ years of experience.
Proven expertise in statistical activities for clinical development programs, including successful regulatory submissions (NDAs, BLAs, or equivalent).
Demonstrated leadership in applying innovative statistical methodologies to enhance clinical trial efficiency.

Department: Direct Clients
This is a full time position

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