Associate Director - Biostatistician

5 days ago

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Kura Oncology, Inc.

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Our mission is to realize the promise of precision medicines to help patients with cancer lead better, longer lives.

Oncology • Precision Medicine • Targeted Therapeutics • Biomarkers • Solid Tumors

51 - 200

💰 $125M Post-IPO Debt on 2022-11

Description

• The Associate Director/Director Biostatistics provides technical leadership and biostatistical support to Clinical Development. • Independently leads the development and execution of statistical aspects for multiple complex clinical trials. • 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. • 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. • 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. • 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. • Takes accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.

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. • Preferably NDA experience, including eCTD submission.

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!