Immunome, Inc.

Immunome, Inc.

Associate Director, Biostatistics

Bothell, Washington, United States · Director

Sponsorship not specifiedDetected 27 days ago
Data AnalysisStatisticsProcess ImprovementClinical TrialsFDA RegulatoryExperimental DesignLeadershipBiostatistics

About the role

  • Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug
  • conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed

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.
  • 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 l ead initiatives in process improvement, training, and standard development.
  • Support ad hoc analyses and develop and validate programs for data analysis, reporting, and visualization.
  • Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
  • The Associate Director of 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.

Requirements

  • 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 leaders
  • PhD or Master's in Biostatistics, Statistics, or a related field.

Benefits

  • 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.

Company info

  • We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates.
  • We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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