Assoc Dir / Director, Statistical Programming

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

ESSENTIAL JOB FUNCTIONS :

The Associate Director / Director of Statistical Programming is responsible for providing technical leadership and programming support to Clinical Development in one or more indications. This individual will collaborate with project biostatisticians, clinical data managers, CRO vendors, and other colleagues in the creation, implementation, and maintenance of statistical programming deliverables for each project. The candidate will support the Head of Statistical Programming to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal / external initiatives.

• Provide leadership and support to project teams on all data programming matters according to the projects' strategies.
• Communicate regularly with CRO vendors to ensure quality and on-time delivery and with members of various internal teams to provide delivery-related updates.
• Lead projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval, and post marketing support.
• Lead design, development, and validation of CDISC submission packages.
• Review CRO statistical programming deliverables and perform acceptance check and validation, to ensure adherence to Statistical Analysis Plan, CDISC standards, and submission readiness.
• Contribute and collaborate across functions for the identification and development of programming standards and macros to facilitate the creation of statistical deliverables, as well as in process improvement activities to ensure high quality and timely statistical programming deliverables.
• Ensure compliance to internal standards and work with line management to identify resource needs based on project milestones and deliverables.
• Mentor junior staff with regard to programming techniques, project management, and implementation of standards.
• Contribute to the recruitment process for programmer positions within the department, both contract and permanent.
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.
• Develop data models, programming standards, and codes as well as train end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
• Implement quality control procedures that are operationally optimized and in compliance with regulatory requirements.
• Support department initiatives and task forces. Participate in departmental or cross-functional working groups and process improvement activities.
• Assist in resource assessments based on in-depth project knowledge, milestones, and deliverables. Implement global resourcing strategy with regard to the use of off-shore operations, outsourcing, and insourcing.
• Effectively interact with external programming resources, including contributing to development and / or review of contract specifications and feedback on performance.
• Contribute to the set up and ongoing maintenance of data transfer processes and programming related applications / systems

JOB SPECIFICATIONS : Basic Qualifications

Preferred Qualifications

The base range for this role at the Associate Director level is $195,476 - $220,000 and Director level is $236,245 - $266,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

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Kura's Values that are used for candidate selection and performance assessments :

The Kura Package

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed / refractory ("R / R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R / R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R / R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R / R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1 / 2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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