Immunome, Inc.

oncology

SeniorDirector,StatisticalProgramming

$272–305k Bothell, Washington, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Senior Director, Statistical Programming at Immunome, Inc.. Skills: Statistical Programming leadership, regulatory submissions, SAS, R. Provide leadership and oversight across clinical programs within Statistical Programming function. managing programming resources”

What You'll Achieve.

Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables

Industry & Context.

oncology
Problems you'll solve

identify and resolve issues

What They're Looking For.

Must Have

PhD or Master in Biostatistics, Statistics, Computer Science or a related field, A minimum of 15 years of experience working in the pharmaceutical, biotech, or CRO industry, Significant oncology is experience is required, Proficiency in statistical programming languages (e.g., SAS, R), Solid experience with reporting process, regulatory requirements, and software development life cycle

Nice to Have

A minimum of five years of leadership experience is strongly preferred

What You'll Do.

Provide leadership and oversight across clinical programs within Statistical Programming function

managing programming resources

assisting in development of Programming infrastructure and process

providing technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements

high-level oversight of CRO partners

technology innovation

cross-functional leadership

Provide leadership and line management to Statistical Programming function

ensuring focus on business priorities and values

Provide management and oversight of statistical programming resources including FTEs

contractors and CROs involved in early-stage and late-stage studies

Ensure quality and timeliness of statistical analysis

and regulatory submission deliverables

Provide hands-on programming

of critical ADAMs and TLFs

Demonstrate technical expertise to promote best practices related programming environments

technology and programming skillsets

Develop and ensure conformation to Programming SOPs and Work Practice guidelines

Maintain strategy for capability and skill development to meet current and future requirements

Maintain an environment to foster creativity and transparency

and a framework for continuous improvement

Drive standardization and innovation to ensure future fitness of the organization

How You'll Work.

Team & Collaboration

work within cross-functional teams; ability to align the company on complex technical decisions; Proven experience in developing and leading high-performing teams; Thrives in a collaborative team setting

Communication Scope

communication skills with ability to align the company on complex technical decisions

Process & Methodology

Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues

Full Job Description

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 Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming function. This position will require managing programming resources, assisting in development of Programming infrastructure and process, providing technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements. This role requires high-level oversight of CRO partners, technology innovation, and cross-functional leadership. Responsibilities Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and values. Provide management and oversight of statistical programming resources including FTEs, contractors and CROs involved in early-stage and late-stage studies. Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables. Provide hands-on programming, if required, of critical ADAMs and TLFs. Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets Develop and ensure conformation to Programming SOPs and Work Practice guidelines Maintain strategy for ca

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