Director, Biostatistics

Role Overview

• Part of clinical development team, as the statistical lead for one or more clinical programs spanning early through late phases (I-III)
• Provide strategic input into clinical development plans, study strategy, study design, endpoint evaluation and selection, estimate development, and analysis strategies.
• Provide innovation in clinical studies with regulatory knowledge to support efficient, risk taking during development
• In collaboration with the study team, oversee and critically review protocols, SAPs, randomization schemes, and interim analysis plans.
• Ensure alignment of statistical approaches with regulatory guidance and standard of care medical practices
• Provide oversight of vendor statistical activities, including deliverable review, issue resolution and budgetary allocation
• Lead statistical contributions to regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Represent Biostatistics in interactions with FDA, EMA, and other global health authorities.
• Ensure statistical outputs are clear, defensible, and aligned with regulatory expectations.
• Establish clear expectations for scientific quality, timelines, and accountability of Data Management and Statistical Programming.
• Support hiring and resourcing strategies that scale with program needs.
• Build fit-for-purpose statistical standards, templates, and processes.
• In collaboration with the Clinical Development and Medical Affairs lead, ensure timely execution of clinical development plans.
• Ensure compliance with ICH, GCP, and internal SOPs.
• Drive consistency and quality across statistical deliverables while enabling flexibility where appropriate.
• Stay current with evolving regulatory guidance and statistical methodologies.
• Champion appropriate innovation, including adaptive designs, Bayesian approaches, and data-driven decision frameworks.

Requirements

• Minimum of Masters of Science in Statistics, Biostatistics
• Minimum of 7 years of experience in biostatistics within pharmaceutical and biotech sponsors with a blend of both
• Demonstrated experience leading statistical activities in Phase I–III clinical trials
• Experience with regulatory submissions and health authority interactions.
• Proven ability to operate effectively in both structured (large pharma) and agile (biotech) development settings.
• Deep understanding of clinical trial design, longitudinal and time-to-event analyses, and estimate frameworks.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Proficiency in SAS
• Experience with complex or innovative trial designs, including hybrid and adaptive models, is a plus.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching