Associate Director/Director, Biostatistician @Kura Oncology

[Hiring] Associate Director/Director, Biostatistician @Kura Oncology

Mar 18, 2025 - Kura Oncology is hiring a remote Associate Director/Director, Biostatistician. 💸 Salary: $180,000 - $250,000 per year. 📍Location: USA.

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Role Description

The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies.

Independently leads the development and execution of statistical aspects for multiple complex clinical trials.
Contributes 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.
Reviews CRF's to ensure analysis data items are included and appropriately captured.
Reviews data validation checks to ensure analysis variable cleaning expectations are included.
Reviews TLF Shells and TLFs.
Reviews SDTM and/or ADaM programming specifications.
Creates a Study Data Standardization plan by program/indication.
Manages 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 statistical and data requirements.
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 in evaluating alternative or innovative methods of analyzing and interpreting data.
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.

Qualifications

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.
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.
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.

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!

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Associate Director/Director, Biostatistician @Kura Oncology

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Salary 💸 $180,000 - $250,000 per year	Remote Location USA
Job Type unspecified	Posted Mar 18, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Associate Director/Director, Biostatistician @Kura Oncology

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