ESSENTIAL JOB FUNCTIONS:

The Associate Director of Statistical Programming is responsible for providing technical leadership and programming support to Clinical Development in one or more projects. 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.

JOB SPECIFICATIONS:

• 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 ADAM 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 Data Science 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.
• Maintain knowledge of new technologies, industry standards, regulatory requirements, and CSO guidelines and SOPs. Implement the quality control procedures that are operationally optimized and in compliance with regulatory requirements.
• Implement the 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 offshore operations, outsourcing, and insourcing.
• Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.

QUALIFICATIONS:

Basic Qualifications

• 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.

Preferred Qualifications

• Experience in ad-hoc programming to produce analysis for various analysis 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 for 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

The base range for an Associate Director is $192,762 - $204,569 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.