Apply on Employer Site

Kura Oncology, Inc. · 1 day ago

Assoc Dir/Director, Statistical Programming

San Diego, CA

Full-time

Onsite

Director/Executive

$195K/yr - $266K/yr

8+ years exp

Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment. The Associate Director/Director of Statistical Programming will provide technical leadership and programming support to Clinical Development, collaborating with various teams to ensure quality statistical programming deliverables for clinical trials.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine

Comp. & Benefits

Responsibilities

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

Qualification

SAS programmingCDISC standardsClinical trial methodologiesRegulatory submission experienceOncology experienceTeam playerCommunication skillsAttention to detailProblem-solving

Required

MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 8+ years of programming experience in the pharmaceutical industry, or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 11+ years of programming experience in the pharmaceutical industry

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

Leverage AI and automation tools to enhance efficiency and streamline programming workflows

Preferred

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)

Knowledge of regulatory requirements concerning electronic submission standards and 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

Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors

Possesses strong written and verbal communication skills

Experience in Oncology therapeutic area