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Our client is a clinical-stage biotechnology company focused on developing innovative therapies for patients with serious central nervous system (CNS) disorders. Their mission is to advance transformative treatments that address significant unmet medical needs and improve the lives of patients and their families. As they continue to progress our clinical programs, they are seeking a strategic and hands-on Senior Director, Biostatistics to join their growing team.

Position Summary
The Senior Director, Biostatistics will provide statistical leadership across the clinical development programs and play a critical role in advancing our assets through key development and regulatory milestones. Reporting to senior clinical development leadership, this individual will serve as the lead statistician for clinical studies, providing expertise in trial design, statistical methodology, analysis planning, data interpretation, and regulatory submissions.

This role is ideal for an experienced biostatistics leader who thrives in a fast-paced biotech environment, enjoys working cross-functionally, and is comfortable rolling up their sleeves to support both strategic and operational activities. The successful candidate will have extensive experience supporting regulatory submissions and managing external CRO partners while contributing to overall development strategy.

Key Responsibilities

• Serve as the statistical lead across clinical development programs, providing strategic and technical leadership from study design through regulatory submission.
• Lead the development and review of study protocols, statistical analysis plans (SAPs), randomization specifications, TLF shells, clinical study reports, and regulatory submission documents.
• Provide statistical expertise for Phase 1, Phase 2, and Phase 3 clinical studies.
• Collaborate closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
• Oversee and manage CROs and external statistical programming vendors to ensure high-quality deliverables, timeline adherence, and regulatory compliance.
• Support interactions with regulatory agencies, including preparation for FDA meetings and responses to health authority questions.
• Guide endpoint selection, sample size calculations, estimand strategies, interim analyses, and overall statistical methodology.
• Review and interpret clinical study results and communicate findings to cross-functional teams and executive leadership.
• Ensure compliance with CDISC standards, ICH guidelines, and regulatory expectations.
• Contribute to clinical development plans, target product profiles, and overall program strategy.
• Support due diligence activities, investor communications, and corporate presentations as needed.
• Help establish and refine biostatistical processes and standards appropriate for a growing biotechnology company.

Qualifications
Required

• PhD in Statistics or Biostatistics.
• Minimum of 10 years of biostatistics experience within the pharmaceutical, biotechnology, or CRO industry.
• Significant experience serving as lead statistician for clinical development programs.
• Demonstrated success supporting NDA, BLA, and/or other major regulatory submissions.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Experience overseeing CROs and external statistical programming resources.
• Knowledge of CDISC standards, including SDTM and ADaM.
• Experience supporting Phase 2 and Phase 3 clinical trials.
• Strong communication, leadership, and influencing skills.
• Ability to work effectively in a lean, fast-moving biotech environment where flexibility and hands-on involvement are essential.

Preferred

• Prior experience in CNS, psychiatry, neurology, neurodegenerative diseases, or other neuroscience therapeutic areas.
• Experience supporting FDA meetings and regulatory interactions.
• Familiarity with adaptive designs, Bayesian methodologies, or innovative clinical trial approaches.
• Previous people leadership and mentoring experience.
• Experience working in small or emerging biotechnology companies.