Our client is a clinical-stage biotech seeking an experienced and strategic Director or Associate Director of Biostatistics to lead and contribute to the planning, execution, and interpretation of statistical analyses for clinical trials. This is a high-impact role supporting drug development programs through every phase, from study design to regulatory submissions. The successful candidate will collaborate with cross-functional teams, interface with global Health Authorities, and manage CROs and vendor partners to ensure the highest standard of statistical excellence.

Key Responsibilities

Director-Level Responsibilities:

• Lead statistical and programming efforts at the product level across multiple clinical trials.
• Provide statistical input into clinical development strategies, study protocols, SAPs, and study reports.
• Ensure high-quality statistical deliverables, including TFLs (tables, figures, listings), for regulatory submissions and internal decision-making.
• Oversee CRO and vendor performance for statistical programming and analysis.
• Participate in global Health Authority interactions, preparing statistical documentation and potentially representing the company in meetings or calls.
• Guide cross-functional teams on data interpretation, regulatory strategy, and safety analyses.

Associate Director-Level Responsibilities:

• Support innovative clinical trial designs that maximize development efficiency and scientific rigor.
• Translate complex statistical concepts for clinical and regulatory audiences.
• Serve as the statistical lead for individual studies or indications, ensuring alignment of data collection and analysis with strategic objectives.
• Provide robust analysis planning, including endpoint selection, hypothesis testing, and data interpretation.
• Collaborate on the development of clinical study protocols, reports, publications, and regulatory documentation.
• Maintain compliance with SOPs and project standards, ensuring statistical quality across deliverables.

Qualifications

Education & Experience Requirements:

• PhD in Statistics, Biostatistics, or related field with 8+ years (Director) or 6+ years (Associate Director) of relevant experience in the biotech/pharmaceutical industry, or Master’s degree with 10+ years (Director) or 8+ years (Associate Director) of experience.
• Proven track record of contributing to or leading successful regulatory submissions (e.g., NDA/BLA).
• Strong understanding of biostatistical methods applied to clinical development and regulatory environments.
• Excellent knowledge of SAS and/or R programming.

Preferred Attributes:

• Demonstrated leadership of cross-functional study teams or statistical teams.
• Effective communicator able to convey complex statistical ideas clearly and persuasively.
• Experience managing CROs or external vendors.
• Flexible, collaborative, and solutions-oriented mindset.
• Up-to-date knowledge of statistical methodology and regulatory guidance.

What They Offer

• A mission-driven, science-focused environment where innovation and teamwork drive development.
• Opportunities to contribute meaningfully to programs with global impact.
• A collaborative culture that values diverse perspectives and continuous learning.
• Competitive compensation and comprehensive benefits.