Associate Director / 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.
Associate Director / Director Biostatistics
The Associate Director / 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 experienceOR 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
Core Competencies
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
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
#LI-Remote
Apply Now
Mineralys is a fully remote company.
Associate Director / Director Biostatistics
The Associate Director / 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 experienceOR 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
Core Competencies
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
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
#LI-Remote
Apply Now