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Avalyn Pharma logo
Avalyn Pharma

Revolutionizing respiratory care with every breath

Director, Biostatistics

DirectorDirectorOtherRemoteLeadTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

122 days ago

Salary

$228K - $245K / year

Seniority

Lead

Postgraduate Degree7 yrs expEnglishGCP

Job Description

Director, Biostatistics

Avalyn Pharma

• 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.

Job 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.

Benefits

  • Health insurance
  • 401(k) matching

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