Head of Biostatistics- Top CNS Biotech - REMOTE (New Rochelle)

Role Description

The Head of Biostatistics – Top CNS Biotech – REMOTE role

Role supporting a leading biotechnology organization focused on central nervous system (CNS) therapies. This leader will oversee all biostatistics activities, including the design, analysis, and interpretation of clinical trials and observational studies. The role includes providing strategic input on clinical development plans, working closely with clinical, regulatory, data management, and medical affairs teams, and ensuring statistical integrity and compliance with regulatory standards. Day-to-day responsibilities involve directing biostatistical methodologies, reviewing protocols and statistical analysis plans, guiding internal and external statisticians, and contributing to submissions and responses to health authorities. The Head of Biostatistics is also expected to build and mentor a high-performing biostatistics function, implement best practices, and support decision-making across the CNS portfolio.

Qualifications

• Advanced training in biostatistics or a related quantitative field (PhD or equivalent strongly preferred), with substantial experience in clinical development for CNS or neurology indications.
• Expertise in clinical trial design, statistical analysis, and interpretation, including Phase I–IV studies and adaptive/innovative designs.
• Proficiency with statistical programming tools (e.g., SAS, R) and familiarity with data standards (e.g., CDISC, SDTM, ADaM) and clinical data management processes.
• Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH), with experience contributing to regulatory submissions and addressing agency questions.
• Demonstrated leadership capabilities, including managing and mentoring biostatistics teams, collaborating in cross-functional settings, and influencing senior stakeholders.
• Excellent communication skills, with the ability to explain complex statistical concepts clearly to non-statistical audiences and contribute to publications and presentations.
• Experience in a biotech or pharmaceutical environment, particularly within CNS, rare disease, or complex therapeutic areas, is highly beneficial.
• Ability to work effectively on-site in New York, NY, with a high