Senior 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 Senior Director of Statistical Programming is a key leader within the Biometrics organization, responsible for overseeing statistical programming activities across multiple clinical programs and regulatory submissions. This individual provides strategic and technical leadership, ensuring timely and high-quality deliverables, and manages internal programming team as well as external vendors and contractors. The role requires strong collaboration with cross-functional stakeholders including biostatistics, clinical development, clinical data manager, medical wring, regulatory, and external partners (CROs and consultants). The individual will also drive innovation, process optimization, and quality standards to support company growth and regulatory compliance.

• Provide leadership and support to project teams on all data programming matters according to the projects’ strategies.
• Communicate regularly with internal programming team and 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.
• Lead 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.
• Hire, manage, and mentor internal programming stuff and contractors 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 SOPs. Implement quality control and oversight procedures that are operationally optimized and in compliance with regulatory requirements.
• Support department initiatives and task forces. Lead/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 invoices, and providing feedback on performance. Serve as the primary point of contact for programming-related activities with CROs.

JOB SPECIFICATIONS:

• Proven track record as a Head of Programming or similar leadership role in the pharmaceutical or biotech industry, with demonstrated success in managing internal teams and overseeing CROs or external vendors
• MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 12+ years of programming experience in the pharmaceutical industry, or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 15+ 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.
• Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
• Strong interpersonal and communication skills, with ability to effectively collaborate in cross-functional teams including biostatistics, clinical operations, data management, medical writing, and regulatory.
• Demonstrated ability to ensure high-quality, compliant, and timely deliverables across all phases of clinical development.
• Experience in building infrastructure, tools, and processes to improve team efficiency and quality.

Preferred Qualifications

• Prior experience in a small biotech setting, serving as Head of Statistical Programming or equivalent leadership role.
• Experience in ad-hoc programming to produce analysis for various projects 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 leading 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.
• Strong technical foundation in statistical programming, data standards, and programming infrastructure, with the ability to provide hands-on technical guidance when needed.

The base range for this role at the Senior Director level is $274,473 - $310,836 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:

• 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 blood cancers and solid tumors. 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, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is 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. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). 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.