Kura Oncology is hiring a
Senior Director Biostatistician

Summary

Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines at Kura Oncology.

Requirements

• Ph.D. degree in statistics and 10+ years of experience
• Experience in both early and late phase clinical development
• Oncology experience preferred
• Proven expertise in complex trial designs, including interim analyses, biomarker and surrogate endpoint evaluations, multiplicity control, and survival analyses
• Experience in regulatory submissions and regulatory interactions
• Strategic thinking capabilities with a proven track record of innovative problem-solving
• Demonstrated ability to lead statistical teams and manage resources effectively for complex programs and submissions
• Team player, with ability to work successfully across functions
• Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms
• Proficiency with statistical programming in SAS and/or R
• Knowledgeable in CDISC standards, including SDTM, ADaM
• Familiar with ICH guidelines, FDA, and other regulatory authority guidance

Responsibilities

• Lead the development and execution of statistical aspects for multiple complex clinical trials
• Provide strategic input on study design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications
• Collaborate with cross-functional teams to drive strategic decision-making in clinical development programs
• Ensure compliance with ICH guidelines, FDA regulations, and other relevant regulatory requirements
• Contribute to the establishment and maintenance of policies, standards, and procedures for biostatistics and programming activities
• Provide mentorship and guidance to junior statisticians
• Develop statistical analysis sections of protocols, statistical analysis plans (SAP), TLF shells, clinical study reports (CSR), regulatory documents or scientific publications
• Generates or reviews study randomization, sample size/power estimations
• Review CRF's to ensure analysis data items are included and appropriately captured
• Review of data validation checks to ensure analysis variable cleaning expectations are included
• Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM
• Oversee vendor management and ensure quality control in externally produced statistical deliverables, such as SAP, SDTM, TLFs Shells, final TLFs
• Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions

Benefits

• 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!