Director Biostatistics

9 hours, 29 minutes ago
Full-time
Lead
Data Science and Analytics
Mineralys Therapeutics

Mineralys Therapeutics

Mineralys Therapeutics is revolutionizing hypertension treatment with lorundrostat, a targeted therapy that normalizes aldosterone levels to reduce the risk of stroke, kidney damage, and heart failure.

Pharmaceuticals
11-50
Founded 2020
$162M raised

Description

  • 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 timely delivery of interim, final, and integrated statistical analyses.
  • Contribute to regulatory submissions, including NDA readiness, and represent Biostatistics in FDA interactions.
  • Collaborate cross-functionally with Clinical, Medical, Regulatory, Statistical Programming, and Data Management teams.
  • Oversee CROs and internal teams to ensure quality, timeliness, and compliance of deliverables.
  • Supervise statistical programmers for QC and validation activities.
  • Interpret analysis results and support study reports, publications, abstracts, posters, and presentations.
  • Drive continuous improvement initiatives within Biostatistics and cross-functional processes.

Requirements

  • PhD in Biostatistics, Statistics, or a related field with approximately 8+ years of industry experience, or an MS with approximately 11+ years of drug development experience.
  • Pharmaceutical or biotech industry experience is required.
  • Demonstrated statistical leadership at the study or program level.
  • Strong experience designing clinical trials and working with cross-functional teams.
  • Experience supporting regulatory submissions such as NDA or BLA.
  • Experience interacting with regulatory authorities is 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 at an oversight level.
  • Experience with outcomes research is preferred.
  • Therapeutic area experience is flexible, with preference for chronic diseases or larger patient populations.
  • Up to 10% travel, including overnight travel, is required.

Benefits

  • Fully remote company.
  • US salary range of $200,000 to $230,000.
  • Medical, dental, and vision coverage.
  • Time off benefits.
  • 401(k) plan.
  • Participation in company incentive plans tied to personal and company performance.

Interested in this position?

Apply directly on the company website

Apply Now

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