Director, Biostatistics

San Diego, CA

Are you ready to join a team committed to making a meaningful impact through precision medicine? By joining Kura, 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 hold precision medicine to a high standard, applying cutting-edge science to create a more personalized approach in the treatment of cancer. We’ve changed the paradigm and improved the science of cancer treatment. We strive to cultivate a diverse and talented professional culture driven to develop therapies and solutions that are as unique as all of us.

As we continue to build a leading biotech organization with a strong culture, relentless execution, and a patient-focused mindset, Kura is planning to grow another 25% this year. To that end, we’re looking for our next innovator to join and help make our vision a reality.To take smart risks in pursuing novel areas of drug research and development and have fun along the way.

To succeed at Kura, you need to have a demonstrated reputation for putting the patient first and foremost, 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.

We’re looking for a Biostatistician Director to join our Clinical Development Team. This position will report to the Chief Medical Officer. This is a newly created position due to growth.

Director, Biostatistics

The Director of Biostatistics is responsible for providing technical leadership, biostatistical and programming support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.

ESSENTIAL JOB FUNCTIONS:

  • Independently leads 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.
  • Participates in establishing and maintaining policies, standards, and procedures for biostatistics and programming activities.
  • Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), 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 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).
  • 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.
  • Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays.
  • Performs and reports study results of statistical analyses to provide interpretation of data and sound study conclusions.
  • Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design.
  • Takes accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.
  • Performs other duties as assigned.

JOB REQUIREMENTS:

  • Bachelor’s degree in relevant statistics field and 7+ 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.
  • Preferably NDA experience, including eCTD submission.

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
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • 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
  • Cell Phone and Wellness 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 was founded in 2014 and has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor currently being evaluated in patients with certain head and neck cancers that carry HRAS mutations. KO-539 is an oral investigational drug candidate we are developing for the treatment of genetically defined AML patients with high unmet needs, currently in a Phase 1/2A clinical trial. KO-539 blocks the interaction of two proteins called menin and MLL that, together, are critically important for survival, growth, and proliferation of certain kinds of leukemia cells.

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. To apply, please submit your resume to careers@kuraoncology.com