Associate Director, Biostatistics

Immunome, Inc. • Bothell, WA

2d

About The Position

The Associate Director of Biostatistics provides important statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. This position collaborates closely with cross-functional teams and provides scientifically rigorous statistical expertise on projects and protocols in support of clinical development and for publication and presentation.

Requirements

• PhD or Master’s in Biostatistics, Statistics, or a related field.
• A minimum of 8 years of experience working in the pharmaceutical, biotech, or CRO industry.
• Proficiency in statistical programming languages (e.g., SAS, R).
• Knowledge of drug submission requirements, relevant ICH and FDA/EMA guidelines.
• Effective verbal and written communication skills.
• Problem-solving skills.
• Attention to detail including proven ability to manage some competing priorities.

Nice To Haves

• A minimum of 1 year of leadership experience is strongly preferred.
• Prior experience in oncology and in regulatory submissions (e.g. NDA, BLA) is a strong plus.

Responsibilities

• Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, and exploratory analyses, support for publication activities, and scientific presentations.
• Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects. For studies with statistical services being outsourced, provide effective vendor management, and monitor vendor performance and ensure compliance with project timelines.
• Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).
• Develop effective collaborations internally (e.g., clinical, clinical data management, clinical programming, statistical programming) to provide statistical support in clinical trials as needed, including inputs for data issues identification, and resolutions.
• Develop and lead initiatives in process improvement, training, and standard development.
• Provide support for ad hoc analyses, and develop and validation programs for data analysis, reporting and visualization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees