Director, Biostatistics

Avalyn Pharma•Cambridge, MA

5d•$228,000 - $245,000

About The Position

The Director of Biostatistics provides strategic and hands-on leadership for statistical activities across clinical development programs. This role combines scientific depth, regulatory rigor, and operational execution to ensure the design, analysis, and interpretation of clinical trials support efficient development and high-quality regulatory submissions. The Director serves as a key partner to Clinical Development, Clinical Operations Data Management, Regulatory Affairs, Medical Affairs and while building scalable biostatistics capabilities appropriate for a growing organization.

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
Strong scientific judgment with the ability to make pragmatic decisions under uncertainty.
Excellent communication skills, with the ability to translate complex statistical concepts for diverse audiences.
Ability to influence senior stakeholders and drive alignment across functions.

Nice To Haves

Therapeutic area experience in chronic, rare, or specialty diseases.
Experience in biotech and big pharma.
Exposure to real-world evidence, external data, or post-marketing studies.
Experience with complex or innovative trial designs, including hybrid and adaptive models, is a plus.

Responsibilities

Statistical Leadership
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
Study Design & Execution
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
Regulatory & Submission Leadership
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.
People & Capability Development
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.
Governance, Quality & Innovation
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.