Kura Oncology

Director, Statistical Programming

San Diego, CA · Director

Sponsorship not specifiedDetected 14 days ago

GCPStatisticsProject ManagementProcess ImprovementCustomer SupportClinical TrialsFDA RegulatorySASResearchLeadershipCommunicationCollaboration

About the role

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines?
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.
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.

Provide leadership and support to project teams on all data programming matters according to the projects' strategies.
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.
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.
Implement global resourcing strategy with regard to the use of off-shore operations, outsourcing, and insourcing.
Manage program resources, including assigning support programmers, overseeing project timelines, and tracking vendor invoices.
We are goal-focused and deliver with excellence

Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
Extensive knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
Knowledge of regulatory requirements concerning electronic submission standards

Experience in ad-hoc programming to produce analysis for various analyses in a short timeframe.
Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
Experience in delivering one or more submissions to regulatory authorities globally.
Experience working with all levels of management and consulting with key business stakeholders.
An ability to influence greater outcomes.
Strong team player that has a customer service approach and is solution oriented.
Possesses strong written and verbal communication skills.
Experience in Acute Myeloid Leukemia (AML) oncology.

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.

Generous stock options
20 days of PTO to start
Generous Benefits Package with a variety of plans available with a substantial employer match

This listing is sourced directly from Kura Oncology's careers page and normalized into a canonical job model.