Mineralys Therapeutics
Director Biostatistics
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 2 weeks ago · Added yesterday
Been open since 2 weeks ago, still being checked, but it has been live a while.
Salary
$200,000 to $230,000
Location
United States only
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
Stated by the employer in the job description
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "US Remote, Remote - US"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
“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 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
Requirements
- ·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)
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Mineralys Therapeutics, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 1d ago. Last checked 23 Sept. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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