Director Biostatistics

As Lead Statistician, you will lead the statistical strategy for one or more clinical programs, serving as a key contributor to clinical development planning, regulatory submissions, and overall data strategy. This role partners closely with cross‑functional program teams and provides hands‑on leadership across study design, analysis, reporting, and oversight of outsourced statistical activities.

Key Responsibilities

• Serve as the biostatistics lead for clinical programs, representing biometrics on program and study teams and providing strategic input to development plans.
• Lead statistical activities for regulatory submissions and inspections, ensuring alignment with FDA, EMA, ICH, and global regulatory expectations.
• Author and review statistical methods sections of clinical protocols and ensure statistical rigor across related study documents.
• Develop, review, and approve Statistical Analysis Plans (SAPs) for individual studies and integrated summaries of safety and efficacy (ISS/ISE).
• Design and review statistical output shells (TLFs) and provide analytical guidance throughout study execution.
• Provide statistical input into CRF design to ensure alignment with study objectives and analysis requirements.
• Oversee and quality‑check outputs from statistical programmers and CRO partners, ensuring accuracy and consistency.
• Author statistical sections of Clinical Study Reports (CSRs) and interpret study results to inform decision‑making.
• Support the preparation of scientific publications, abstracts, and presentations.
• Manage relationships with CRO partners to ensure timely, high‑quality statistical deliverables.
• Provide leadership, mentorship, and professional development to direct reports, as applicable.

Skills & Experience

• Advanced degree in Statistics or a related field with 6+ years of clinical trial experience in a biotech or pharmaceutical setting.
• Strong command of statistical methods for clinical trials, with deep knowledge of FDA, EMA, and ICH guidelines.
• Advanced proficiency in SAS; experience with R and/or Python is a plus.
• Familiarity with trial‑design tools such as EAST or nQuery preferred.
• Excellent communication skills, with the ability to clearly explain complex statistical concepts to non‑statistical audiences and influence decision‑making.
• Demonstrated ability to manage multiple priorities in a fast‑paced development environment.
• Strong interest in innovation, methodological advancement, and continuous process improvement in biostatistics.

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