Head of Biostatistics (Contract Research Organization)
Piper Companies · United States
- Hybrid
- Contract
- $290,000 / year
- United States
Job highlights
- Lead biostatistical strategy for a CRO.
- Oversee clinical trial statistical design and analysis.
- Ensure regulatory compliance and statistical integrity.
- Mentor and develop senior biostatistics teams.
- Partner with sponsors and internal stakeholders.
About the role
Head of Biostatistics
Piper Companies is seeking a Head of Biostatistics to lead and oversee biostatistical strategy and execution for a Contract Research Organization. The Head of Biostatistics role is a senior leadership position focused on scientific oversight, regulatory excellence, and statistical integrity across clinical development programs. The Head of Biostatistics will ensure high-quality statistical design, analysis, and reporting while serving as a key scientific partner to sponsors and internal stakeholders.
Responsibilities of the Head of Biostatistics:
- Provide strategic and scientific leadership for biostatistics across all phases of clinical development within a CRO.
- Oversee statistical design, analysis plans, and interpretation of clinical trial data to support regulatory submissions.
- Serve as the senior statistical authority for client engagements, regulatory interactions, and internal governance committees.
- Ensure compliance with FDA, EMA, ICH, and other global regulatory standards for statistical methodologies and reporting.
- Collaborate closely with clinical operations, data management, and programming teams to ensure seamless study execution.
- Lead, mentor, and develop senior biostatistics leaders and statistical teams across multiple therapeutic areas.
- Contribute to proposal development, study feasibility assessments, and scientific strategy without direct P&L ownership.
Qualifications of the Head of Biostatistics:
- 10+ years of biostatistics leadership experience within a Contract Research Organization (CRO).
- Recent CRO experience supporting clinical trials across multiple phases and therapeutic areas.
- Advanced degree in Biostatistics, Statistics, or a related field.
- Deep expertise in clinical trial statistical design, analysis methodologies, and regulatory submission support.
- Strong knowledge of global regulatory expectations and industry best practices.
- Proven ability to lead senior-level teams and act as a trusted scientific advisor to sponsors.
Compensation for the Head of Biostatistics includes:
- Salary range: $280,000 – $300,000 depending on experience
- Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
Key skills/competency
- Biostatistics Leadership
- Clinical Trial Design
- Statistical Analysis
- Regulatory Submissions
- CRO Experience
- FDA/EMA/ICH Compliance
- Team Leadership
- Scientific Strategy
- Data Interpretation
- Biostatistics
Skills & topics
- Head of Biostatistics
- Biostatistics
- Statistics
- Clinical Trials
- CRO
- Regulatory Affairs
- FDA
- EMA
- ICH
- Leadership
How to get hired
- Tailor your resume: Highlight your 10+ years of CRO biostatistics leadership experience.
- Showcase regulatory expertise: Emphasize your knowledge of FDA, EMA, and ICH guidelines.
- Demonstrate leadership skills: Provide examples of mentoring senior teams and advising sponsors.
- Prepare for technical questions: Be ready to discuss clinical trial design and analysis methodologies.
- Express strategic thinking: Articulate your approach to biostatistical strategy and execution.
Technical preparation
Review clinical trial statistical design principles.,Study common analysis methodologies and reporting standards.,Familiarize with FDA, EMA, and ICH guidelines.,Practice interpreting clinical trial data.
Behavioral questions
Describe a time you led a senior statistical team.,How have you advised sponsors on statistical strategy?,Discuss your approach to ensuring regulatory compliance.,Share an experience of cross-functional collaboration.
Frequently asked questions
- What is the primary focus of the Head of Biostatistics role at Piper Companies?
- The Head of Biostatistics at Piper Companies will provide strategic and scientific leadership for biostatistics across all phases of clinical development within a Contract Research Organization. This includes overseeing statistical design, analysis plans, and interpretation of clinical trial data, ensuring regulatory compliance and acting as a senior statistical authority.
- What qualifications are essential for the Head of Biostatistics position?
- Essential qualifications include over 10 years of biostatistics leadership experience in a CRO, recent CRO experience with multi-phase clinical trials, an advanced degree in Biostatistics or Statistics, deep expertise in clinical trial statistical design and analysis, and strong knowledge of global regulatory expectations.
- What is the salary range for the Head of Biostatistics position?
- The salary range for the Head of Biostatistics position is $280,000 to $300,000 annually, depending on the candidate's experience. This is in addition to a comprehensive benefits package.
- Does this Head of Biostatistics role require direct P&L ownership?
- No, the Head of Biostatistics role at Piper Companies does not include direct P&L ownership. The responsibilities focus on scientific strategy, leadership, and execution within the biostatistics function.
- What kind of collaboration is expected for the Head of Biostatistics?
- The Head of Biostatistics is expected to collaborate closely with clinical operations, data management, and programming teams to ensure seamless study execution. They will also serve as a key scientific partner to sponsors and internal stakeholders.
- How does Piper Companies ensure adherence to regulatory standards in this role?
- The Head of Biostatistics is responsible for ensuring compliance with FDA, EMA, ICH, and other global regulatory standards for statistical methodologies and reporting, maintaining statistical integrity across all clinical development programs.