Associate Director, Biostatistics jobs in United States
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Immunome, Inc. · 1 day ago

Associate Director, Biostatistics

Immunome is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Associate Director of Biostatistics is responsible for providing statistical support for clinical studies, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements in clinical development projects.

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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

Qualification

BiostatisticsStatistical programmingOncology experienceRegulatory submissionsCommunication skillsProblem-solving skillsAttention to detail

Required

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
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
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

Company

Immunome, Inc.

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Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

H1B Sponsorship

Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)

Funding

Current Stage
Public Company
Total Funding
$998.85M
Key Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M

Leadership Team

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Clay Siegall
President and CEO
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Purnanand D. Sarma
President & CEO
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Recent News

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