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Salary: USD 200,000 - 230,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines for hypertension, chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a selective aldosterone synthase inhibitor.
The Director of Biostatistics will lead all statistical strategy and execution for clinical development programs. This role is accountable for designing, analyzing, and interpreting clinical trials, as well as providing statistical contributions to regulatory submissions and NDA readiness. Operating in a fast-paced, pre-commercial biotech environment, the position requires balancing strategic thinking with operational oversight and maintaining high visibility across Clinical, Medical, and Regulatory teams.
Key responsibilities include: leading the full scope of biostatistics activities for assigned clinical programs; defining and executing statistical strategies for clinical trials and regulatory submissions; designing clinical studies including endpoints, estimands, and sample size calculations; serving as statistical lead on Study Executive Teams and Clinical Development Teams; providing quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success; ensuring quality and timely delivery of statistical outputs including interim, final, and integrated analyses; contributing to regulatory submissions (e.g., NDA) and representing Biostatistics in FDA interactions; collaborating cross-functionally with Clinical, Medical, and Regulatory teams; overseeing CROs and/or internal teams to ensure quality, timeliness, and compliance; collaborating with internal leaders of Statistical Programming and Data Management; supervising statistical programmers for QC and validation activities; interpreting analysis results and ensuring accuracy in study reports, publications, and regulatory documents; contributing to abstracts, posters, and presentations; and driving continuous improvement initiatives.
Required 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 is required. Candidates must demonstrate experience providing statistical leadership at study or program level, strong experience designing clinical trials and collaborating cross-functionally, experience supporting regulatory submissions (NDA/BLA), experience overseeing CROs or external vendors, experience supervising programming deliverables or QC activities, strong knowledge of CDISC standards and statistical methodologies, and working knowledge of SAS and/or R at an oversight level. Experience interacting with regulatory authorities and outcomes research is preferred. Therapeutic area experience is flexible with preference for chronic diseases or larger patient populations.
Core competencies include strong understanding of clinical development processes and regulatory expectations, ability to lead and influence in a matrixed environment, excellent communication skills with ability to translate statistical concepts to non-statistical audiences, demonstrated ability to balance urgency with quality, analytical rigor with pragmatic execution-oriented mindset, and experience applying innovative statistical methodologies. The position requires up to 10% travel, frequently outside the local area and overnight.
