Associate Director, Statistical Programming - Kura Oncology
San Diego, CA
About the Job
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 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.
Kura's Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.
Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.
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.