Associate Director / Director, Biostatistics at Immunome, Inc.

Bothell, Washington, United StatesFull-timeDevelopmentPosted about 2 months ago

About the Role

<div class="content-intro">Company Overview <div class="x_elementToProof" data-olk-copy-source="MessageBody"> <div data-olk-copy-source="MessageBody">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.</div> </div></div>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 <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Apply rigorous statistical expertise to study design, statistical analysis plans, interpretation of results, project development plans, and regulatory issues.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Plan, deliver, and communicate statistical analyses and scientific reports, including clinical trial and exploratory analyses, and support publications and scientific presentations.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Ensure all study- and project-level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Collaborate with internal partners (e.g., clinical development, clinical data management, statistical programming) to provide statistical support and help identify and resolve data issues.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Develop and lead initiatives in process improvement, training, and standard development.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Support ad hoc analyses and develop and validate programs for data analysis, reporting, and visualization.  </li> </ul> Qualifications <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1">PhD or Master’s in Biostatistics, Statistics, or a related field.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1">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.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1">A minimum of 2 years of leadership or people-management experience is preferred.  </li> </ul> Knowledge and Skills <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Prior oncology clinical trial experience, including familiarity 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).</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Experience supporting regulatory submissions (e.g., NDA, BLA) is a strong plus.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Proficiency in statistical programming languages (e.g., SAS, R); experience using simulation to support trial design is a plus.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Knowledge of CDISC data standards (SDTM and ADaM).</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Knowledge of drug submission requirements and relevant ICH and FDA/EMA guidelines, including the ICH E9(R1) estimand framework.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Strong verbal and written communication skills, including the ability to convey complex statistical concepts to cross-functional, non-statistical audiences.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Strong problem-solving skills and the ability to work both independently and collaboratively in a fast-paced environment.</li> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1">Strong attention to detail and a proven ability to manage multiple competing priorities. </li> </ul>   Washington State Pay Range - Associate Director: $200,850 - $227,316 Washington State Pay Range - Director: $235,000 - $263,700  <div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range">$200,850—$263,700 USD</div></div></div><div class="content-conclusion">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: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</div>

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