Associate Director, Biostatistician

Summary

Join Kura Oncology, a leading biotech company committed to precision medicine in cancer treatment, and contribute to our mission of improving patient outcomes. As an Associate Director/Director of Biostatistics, you will provide technical leadership and biostatistical support for clinical studies, from design and data review to regulatory submissions. You will independently lead statistical aspects of complex clinical trials and contribute to study design, analysis, and reporting. This role requires a Ph.D. in statistics with 7+ years of experience (or a master's degree with 10+ years of experience) in the pharmaceutical or biotech industry. Kura offers a competitive compensation package, including generous benefits, equity, and a bonus, along with opportunities for career advancement and a supportive work environment.

Requirements

• Ph.D. degree in statistics and 7+ years of experience (or master's degree in relevant statistics field and 10+ years of clinical trial experience) in the pharmaceutical or biotech companies, or related experience or equivalent combination of training and experience
• Proven knowledge and expertise in statistics and its applications to clinical trials
• 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
• Demonstrated leadership skills
• 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

• Provide technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies
• Review and ensure accuracy of clinical data
• Evaluate, interpret, and report study results
• Support regulatory submissions to the FDA and other regulatory agencies
• Independently lead the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications
• Participate in establishing and maintaining policies, standards, and procedures for biostatistics and programming activities
• Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications
• Generate or review 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 TLF Shells and TLFs
• Review of SDTM and/or ADaM programming specifications
• Review of vendor data transfer specifications for that data will be included in SDTM
• Creation of a Study Data Standardization plan by program/ indication
• Ad hoc review of displays in support of publications/meeting, IDMB
• Manage timelines for creation/review/approval for stats/programming activities (SAP, SDTM, TLFs Shells, final TLFs)
• Provide 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
• Develop statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays
• Perform and report study results of statistical analyses to provide interpretation of data and sound study conclusions
• Provide leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design
• Take accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project
• Perform other duties as assigned

Preferred Qualifications

• NDA experience, including eCTD submission
• Oncology experience

Benefits

• 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!
• Career advancement/ development opportunities