Company Overview:

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

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.

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.

Qualifications

• 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.

Technical & Regulatory Expertise

• 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.

Leadership & Communication

• 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.

Preferred Experience

• 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.

Core Competencies

• Strategic and analytical thinking
• Scientific and regulatory rigor
• Execution-focused leadership
• Cross-functional collaboration
• Adaptability and sound judgment