Associate Director / 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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

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 .
• 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 - Associate Director: $200,850 - $227,316

Washington State Pay Range - Director: $235,000 - $263,700

Washington State Pay Range $200,850 — $263,700 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).