生物统计总监
Director Biostatistics
Mineralys Therapeutics是一家处于临床阶段的生物制药公司，专注于开发针对高血压及其相关合并症（如慢性肾病（CKD）、阻塞性睡眠呼吸暂停（OSA）和其他由醛固酮失调驱动的疾病）的药物。其首个候选药物lorundrostat是一种专有、口服、高度选择性的醛固酮合成酶抑制剂。Mineralys总部位于宾夕法尼亚州Radnor。更多信息，请访问https://mineralystx.com。关注Mineralys的LinkedIn、Twitter和Bluesky。
Mineralys是一家完全远程办公的公司。
生物统计学总监
生物统计学总监将负责Mineralys临床开发项目的全部统计策略和执行工作。该职位对临床试验的设计、分析和解释以及监管提交（包括NDA准备）的统计贡献负有责任。
在快速发展的、尚未商业化的生物科技环境中，该职位需要具备战略思维和运营管理的平衡能力，并在临床、医学和监管团队中具有高度可见性。
主要职责
- 领导指定临床项目或适应症的全部生物统计学活动
- 制定并执行临床试验和监管提交的统计策略
- 设计临床研究，包括终点、估计量和样本量计算
- 作为统计负责人参与研究执行团队和临床开发团队
- 提供临床开发计划中的定量输入，包括是否继续的决策标准和技术成功概率
- 确保统计输出的质量和及时交付，包括中期、最终和综合分析
- 参与监管提交（例如NDA），并在与FDA的互动中代表生物统计学部门
- 跨职能与临床、医学和监管团队合作
- 监督CRO和/或内部团队；确保交付成果的质量、及时性和合规性
- 与统计编程和数据管理的内部领导合作
- 监督统计程序员进行质量控制和验证活动
- 解释分析结果，确保研究报告、出版物和监管文件中的准确性
- 为内部和外部利益相关者撰写摘要、海报和演示文稿
- 推动生物统计学领域的持续改进计划
查看英文原文
“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
- 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
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