Immunome, Inc.
oncology
SeniorDirector,StatisticalProgramming
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optimal for Director candidates.
“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.
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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