Associate Director / Director, Biostatistics
Immunome, Inc.About the role
Company Overview
Position Overview
The Associate Director / Director, Biostatistics provides 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.
Responsibilities
- Apply rigorous statistical expertise to study design, statistical analysis plans, interpretation of results, project development plans, and regulatory issues.
- Provide strategic statistical input into clinical development plans and study-level decision-making, anticipating downstream regulatory and data implications to inform study design and overall development strategy.
- Plan, deliver, and communicate statistical analyses and scientific reports, including clinical trial and exploratory analyses, and support publications and scientific presentations.
- Own the timeliness and quality of study- and submission-level statistical deliverables on assigned projects. For outsourced studies, manage vendors and monitor their performance and adherence to project timelines.
- Ensure all study- and project-level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).
- Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for regulatory meetings, responses to health authority questions, and preparation for advisory committee meetings.
- Collaborate with internal partners (e.g., clinical development, clinical data management, statistical programming) to provide statistical support and help identify and resolve data issues.
- Develop and lead initiatives in process improvement, training, and standard development.
- Support ad hoc analyses and develop and validate programs for data analysis, reporting, and visualization.
Qualifications
- PhD or Master’s in Biostatistics, Statistics, or a related field.
- A minimum of 6 years (with a PhD) or 8 years (with a Master's) of biostatistics experience supporting clinical trials in the pharmaceutical, biotech, or CRO industry, or equivalent.
- A minimum of 2 years of leadership or people-management experience is preferred.
Knowledge and Skills
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