Director Biostatistics

The Director, Biostatistics will lead the full scope of statistical strategy and execution for clinical development programs at Mineralys. This individual is accountable for the design, analysis, and interpretation of clinical trials, as well as statistical contributions to regulatory submissions, including NDA readiness.

Operating in a fast-paced, pre-commercial biotech environment, this role requires a strong balance of strategic thinking and operational oversight, with high visibility across Clinical, Medical, and Regulatory teams.

Key Responsibilities

• Lead the full scope of Biostatistics activities for assigned clinical programs or indications
• Define and execute statistical strategies for clinical trials and regulatory submissions
• Design clinical studies, including endpoints, estimands, and sample size calculations
• Serve as statistical lead on Study Executive Teams and Clinical Development Teams
• Provide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success
• Ensure quality and timely delivery of statistical outputs, including interim, final, and integrated analyses
• Contribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDA
• Collaborate cross-functionally with Clinical, Medical, and Regulatory
• Oversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverables
• Collaborate with internal leaders of Statistical Programming and Data Management
• Supervise statistical programmers for QC and validation activities
• Interpret analysis results and ensure accuracy in study reports, publications, and regulatory documents
• Contribute to abstracts, posters, and presentations for internal and external stakeholders
• Drive continuous improvement initiatives within Biostatistics and cross-functional processes

Qualifications

• PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience
  OR MS with ~11+ years of experience in drug development
• Pharmaceutical/biotech industry experience required
• Demonstrated experience providing statistical leadership at study or program level
• Strong experience designing clinical trials and collaborating with cross-functional teams
• Experience supporting regulatory submissions ( NDA/BLA )
• Experience interacting with regulatory authorities preferred
• Experience overseeing CROs or external vendors
• Experience supervising programming deliverables or QC activities
• Strong knowledge of CDISC standards , data structures, and statistical methodologies
• Working knowledge of SAS and/or R (oversight level, not heavy programming)
• Experience with outcomes research preferred
• Therapeutic area experience flexible; preference for chronic diseases or larger patient populations

Core Competencies

• Strong understanding of clinical development processes and regulatory expectations
• Ability to lead and influence in a matrixed environment
• Excellent communication skills; able to translate statistical concepts to non-statistical audiences
• Demonstrated ability to balance urgency with quality
• Analytical rigor with a pragmatic, execution-oriented mindset
• Experience applying innovative statistical methodologies

Travel

• This position requires up to 10% travel . Frequently travel is outside the local area and overnight.

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance.