Company Confidential - Greater Boston Area
Full Time - Permanent
Overview
We’re looking for a proven Biostatistics leader to play a central role in shaping clinical trial strategy and data interpretation across multiple precision neurology programs. This position reports to the head of Biometrics and works closely with cross-functional partners to drive statistical excellence and ensure data integrity throughout development.
Strategic Impact
- Provide statistical leadership in the design and execution of clinical studies.
- Author and review statistical components of protocols, analysis plans, and clinical reports.
- Partner with clinical, regulatory, and data science teams to influence study design and development strategy.
Execution & Analysis
- Conduct and validate analyses of trial data using SAS, R, or Python in line with internal and regulatory standards.
- Lead the creation of tables, figures, and listings; support interpretation of outcomes for internal and external audiences.
- Ensure adherence to CDISC standards (SDTM, ADaM) and global regulatory expectations (FDA, EMA, ICH).
- Manage statistical deliverables from CROs and external vendors, ensuring accuracy and timeliness.
Collaboration & Governance
- Contribute to the design of data collection tools and case report forms to ensure clean, analyzable data.
- Support preparation of regulatory filings, including INDs and NDAs.
- Guide development of internal best practices, SOPs, and statistical methodologies.
- Participate in resource planning and team development within Biometrics.
Qualifications
- PhD with 10+ years (12+ for Senior Director) or MS with 12+ years (15+ for Senior Director) in statistics, biostatistics, or a closely related field.
- Deep experience in the biopharmaceutical industry, ideally with exposure to neurological or CNS drug development.
- Expertise in statistical programming (SAS, R, or Python) for analysis, visualization, and simulation.
- Strong working knowledge of advanced clinical trial design, statistical methods, and regulatory guidance.
- Demonstrated success managing CROs, timelines, and deliverables in a global regulatory environment.
- Proven ability to communicate complex concepts clearly to diverse audiences.
- Excellent organization, leadership, and project management skills.