Associate Director, Biostatistics

Company Overview 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 solid tumor targets. Position Overview 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.    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 . E nsure  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 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 .     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 Prior  oncology  clinical trial  experience, including familia rity with standard response criteria (e.g. , RECIST  1.1), oncology endpoints (e.g., overall survival, progression-free survival, objective response rate), and associated statistical methodology (e.g., survival/time-to-event analysis, group sequential and adaptive designs ) . Experience supporting regulatory submissions (e.g.,  NDA, BLA)  is   a strong plus. Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus. Proficiency  in statistical programming languages (e.g., SAS, R) ;  experience using simulation to support trial design is  a plus . Knowledge of CDISC data standards (SDTM and ADaM ). K nowledge of drug submission requirements  and  relevant ICH and FDA/EMA guidelines , including the ICH E9(R1)  estimand  framework . Strong  verbal and written communication skills , including the ability to convey complex statistical concepts to cross-functional, non-statistical audiences . Strong problem-solving skills and the ability to work both independently and collaboratively in a fast-paced environment . Strong attention to detail and a  proven ability to manage  multiple  competing priorities.   Washington State Pay Range $200,850 — $227,316 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish) .