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. 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 indicationsDefine and execute statistical strategies for clinical trials and regulatory submissionsDesign clinical studies, including endpoints, estimands, and sample size calculationsServe as statistical lead on Study Executive Teams and Clinical Development TeamsProvide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical successEnsure quality and timely delivery of statistical outputs, including interim, final, and integrated analysesContribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDACollaborate cross-functionally with Clinical, Medical, and RegulatoryOversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverablesCollaborate with internal leaders of Statistical Programming and Data ManagementSupervise statistical programmers for QC and validation activitiesInterpret analysis results and ensure accuracy in study reports, publications, and regulatory documentsContribute to abstracts, posters, and presentations for internal and external stakeholdersDrive 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 developmentPharmaceutical/biotech industry experience requiredDemonstrated experience providing statistical leadership at study or program levelStrong experience designing clinical trials and collaborating with cross-functional teamsExperience supporting regulatory submissions (NDA/BLA)Experience interacting with regulatory authorities preferredExperience overseeing CROs or external vendorsExperience supervising programming deliverables or QC activitiesStrong knowledge of CDISC standards, data structures, and statistical methodologiesWorking knowledge of SAS and/or R (oversight level, not heavy programming)Experience with outcomes research preferredTherapeutic area experience flexible; preference for chronic diseases or larger patient populations Core Competencies Strong understanding of clinical development processes and regulatory expectationsAbility to lead and influence in a matrixed environmentExcellent communication skills; able to translate statistical concepts to non-statistical audiencesDemonstrated ability to balance urgency with qualityAnalytical rigor with a pragmatic, execution-oriented mindsetExperience 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. 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