Principal Biostatistician Consultant

Principal Biostatistician Consultant (Project needs of 10-20 hours per week)

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

 The Opportunity

Denali Therapeutics is seeking to recruit an experienced Principal Biostatistician Consultant. The candidate will lead Biostatistics planning activities and deliverables in support of Denali’s core clinical development programs and help shape strategies for clinical development programs. The ideal candidate will guide analytical aspects of a core program entering late stage development, inform study designs, develop and implement novel statistical and computational techniques for analyzing data generated both in house and by external CROs, lead reporting and analysis deliverables, and use a combination of curiosity and statistical acumen to identify and solve interesting problems. This position will report to the Senior Director of Biometrics.

Responsibilities

• Devise and lead statistical strategies for clinical development of drug candidates including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
• Ensure statistical integrity of analysis and reporting deliverables, including guidance on statistical methodology, optimization of study designs, endpoint selection, author/review statistical sections of the protocol, clinical study reports and related documents, oversee timelines and study level tasks pertaining to statistical analysis and reporting.
• Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed.
• Consult on methodologies for modeling large scale data (e.g., metabolomics, genetic).
• Interpret, summarize and present data and statistical considerations to internal project teams, senior management, advisory board meetings and to global health authorities.
• Collaborate with Clinical Operations to select, oversee, contract, and manage Biostatistics vendors and contract research organizations.
• Teach Stats basics and/or create standard tools and practices to enable colleagues to visualize and gain insights from their data.
• Seek out interesting problems and use Statistics to solve them.

Requirements

• Ph.D. in Statistics or Biostatistics with clinical development experience in multiple programs.
• Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology setting.
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities.
• Strong analytical and problem-solving skills; expert collaboration and communication skills.
• Experience working with orphan indications highly desired.
• Strong programming skills in R, Shiny, Markdown; working knowledge of Git and Unix/Linux environments.
• Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.
• Ability and interest to work cross functionally.
• Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture.