Avalyn Pharma · 18 hours ago
Director, Biostatistics
United States
Full-time
Remote
Director/Executive
$228K/yr - $245K/yr
7+ years expAvalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases. The Director of Biostatistics provides strategic and hands-on leadership for statistical activities across clinical development programs, ensuring high-quality regulatory submissions and innovative clinical study designs.
BiotechnologyHealthcarePharmaceuticalBiopharmaMedical
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
Avalyn Pharma
Avalyn Pharma is a biopharma company developing therapies for the treatment of idiopathic pulmonary fibrosis and other respiratory diseases.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$372.5MKey Investors
SR One,Suvretta Capital ManagementEventide,Perceptive Advisors,SR OneNorwest
2025-07-22Series D· $100M
2023-09-27Series C· $175M
2020-04-27Series B· $35.5M
Leadership Team
Douglas Carlson
Chief Financial Officer / Chief Business Officer
Melissa Rhodes
Chief Operating Officer
Recent News
2025-11-03
Avalyn Pharma Inc.
2025-10-21
Avalyn Pharma Inc.
2025-10-01
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