Director Biostatistics

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

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.

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

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

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

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. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range: $200,000 - $230,000

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