Kura Oncology, Inc. · 6 days ago
Executive Director, Head of Biostatistics
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BiopharmaBiotechnology
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Responsibilities
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.
Qualification
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Required
Ph.D. degree in statistics and 12+ years of experience (or master's degree in relevant statistics field and 15+ 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.
Preferred
Preferably NDA experience, including eCTD submission.
Benefits
Career advancement/development opportunities
Competitive compensation 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!
Company
Kura Oncology, Inc.
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.
Funding
Current Stage
Public CompanyTotal Funding
$1.24BKey Investors
Bristol-Myers SquibbHercules CapitalEcoR1 Capital
2024-01-24Post Ipo Equity· $150M
2023-06-14Post Ipo Equity· $100M
2022-11-03Post Ipo Equity· $25M
Recent News
2024-06-05
Investor's Business Daily
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2024-06-05
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