adaptive designsasfdastatistical methodsbiostatisticsclinical trial designcdisc sdtmcdisc adam
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Чётко очерченная руководящая роль в крупной компании клинических исследований с влиянием на дизайн испытаний и научную работу; требования к опыту высокие, также предусмотрена работа с клиентами.
?Высокий порог опыта
Научное лидерство
Гибкий формат роли
?Работа с клиентами
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Текст:
Hirify AI/Оригинал
TL;DR
Biostatistics Director- Global BIOS (Clinical Trial Design): Leading statistical methodology and consultancy for complex clinical trial and program designs with an accent on adaptive designs, biosimilars, master protocols, Bayesian analyses, and endpoint selection. Focus on advising internal and external clients, contributing to protocol synopses, serving as a subject matter expert, and presenting statistical work through publications, conferences, and webinars.
Location: Durham, North Carolina, United States; Kirkland, Quebec, Canada. This position can be either home- or office-based.
Annualized base pay: $134,800.00–$375,700.00, with the actual offer varying by qualifications, location, and schedule.
Company
hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
Provide high-level statistical guidance to internal and external clients on clinical trial and program design.
Lead a specialized area of statistical methodology as a subject matter expert and support general statistical consulting.
Contribute to protocol synopses and, occasionally, full protocols and advanced statistical analyses with medical, pharmacokinetic, and operational experts.
Support data monitoring committees as a blinded or unblinded statistician.
Develop thought leadership through peer-reviewed publications, peer review and editor work, scientific conference presentations, and invitation-only webinars.
Participate in bid defences, client travel, and potentially people and project management.
Requirements
PhD or MSc in Statistics, Biostatistics, or a related field, with 11 to 13+ years of experience in the life-science industry; PhD preferred.
Strong knowledge of complex statistical methods applicable to clinical trials.
Experience with clinical trial design; adaptive design experience strongly preferred.
Knowledge of regulatory bodies and compliance in the pharmaceutical and CRO space; FDA experience preferred.
Strong working knowledge of SAS and CDISC SDTM and ADaM.
Ability to manage multiple tasks and projects and communicate and explain statistical concepts effectively.
Experience preparing budgets and proposals and participating in bid defences.
Experience publishing papers or presenting talks at scientific conferences and/or webinars.
Culture & Benefits
Interesting and innovative projects.
Collaborative and inspirational working environment.
Career development and progression opportunities.
Work-life balance.
Home-based or office-based work arrangement.
Incentive plans, bonuses, and health and welfare benefits may be offered depending on the position.
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