Jobs · Manufacturing · California

Associate Director, Biometrics

Ionis Pharmaceuticals, Inc. · Carlsbad, CA · 1 wk ago
Manufacturing$165k–$223k/yrFull-time

Headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been discovering medical breakthroughs for more than three decades. We’re pioneers in RNA-targeted medicines, revolutionizing drug discovery and transforming lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology, and other high-need areas, we drive innovation in RNA therapies and advance new approaches in gene editing. Our challenging, motivating, and rewarding environment fosters innovation and scientific excellence, and we invest in making our onsite, hybrid, and remote work environments thrive.

About the role

The Associate Director, Biometrics is an experienced leadership position requiring broad knowledge and sound judgment within biostatistics. This role is responsible for the Biostatistics components of assigned projects, including study design, document review, statistical analysis, and CRO oversight. You will contribute to therapeutic area strategy, ensuring operational efficiency and high scientific integrity in clinical development.

Responsibilities

  • Provide statistical leadership and independent guidance for assigned clinical development programs/projects, including study design, analysis, interpretation, and development strategy.
  • Serve as the statistical lead on cross-functional study and project teams, providing recommendations on complex statistical issues.
  • Lead statistical strategy and execution across assigned studies, ensuring scientific rigor, consistency, and alignment with regulatory and industry standards.
  • Design clinical trials and provide statistical guidance on clinical development projects.
  • Provide sample size estimates for proposed studies.
  • Write statistical sections of study protocols, statistical analysis plans, and study reports.
  • Develop clinical trial randomization.
  • Review study protocols, CRFs, database structures, study reports, and annual reports.
  • Lead study or project teams in the review and discussion of Statistical Analysis Plans (SAP).
  • Oversee CRO statistical activities and deliverables, including quality, timelines, and implementation of statistical analysis plans.
  • Maintain study documentation of statistical analyses and supportive documents.
  • Perform other duties as assigned.

Requirements

  • PhD in Statistics, Biostatistics, or a related field with at least 5 years of relevant experience, or a master’s degree in Statistics, Biostatistics, or a related field with at least 8 years of relevant experience.
  • Proficient with SAS programming and other statistical software (e.g., R).
  • Proven knowledge of CDISC (Clinical Data Interchange Standards Consortium) standards and their application to projects.
  • Demonstrates advanced oral and written communication skills.

Benefits

Ionis offers an excellent benefits package. Learn more about our benefits.

Pay

The pay scale for this position is $164,760 to $222,888.

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