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Associate Director, Biostatistics - Genetic Medicine

176 100 - 287 300$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Director, Biostatistics - Genetic Medicine (Biostatistics/Clinical Development): Designing and analyzing clinical trials for genetic medicine programs with an accent on endpoint feasibility, statistical methodology, regulatory interactions, and cross-functional drug development. Focus on developing analysis plans, interpreting trial results, improving statistical processes, and mentoring statisticians.

Location: Tarrytown, New York or Warren, New Jersey; 4 days per week onsite

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

  • Represent Biostatistics on global clinical sub-teams and collaborate with medical, clinical, regulatory, preclinical, programming, data management, and medical writing functions.
  • Define drug development questions, assess endpoint feasibility, develop statistical approaches, and design clinical experiments and interventional studies.
  • Analyze clinical trial data, interpret results, and support project and management decision-making.
  • Prepare regulatory materials, including statistical analysis plans, tables, figures, listings, and advisory committee presentations.
  • Lead process improvement, technical working groups, SOP development, and cross-functional EPIC workstreams.
  • Develop training for non-statisticians, contribute to innovative statistical research, and mentor less experienced statisticians.

Requirements

  • PhD or equivalent in statistics or biostatistics with more than 6 years of pharmaceutical industry experience, or an MS in statistics or biostatistics with more than 11 years of experience.
  • Strong knowledge of statistical analysis methodologies and experimental and clinical trial design.
  • Expertise in statistical software and experience with time-to-event analyses.
  • Knowledge of drug discovery and development and the ability to integrate statistical concepts into development strategies.
  • Demonstrated leadership, collaboration, critical thinking, time management, and communication skills.
  • Ability to work productively in a fast-paced, cross-functional environment.

Nice to have

  • Experience in hematology, immuno-oncology, non-oncology, multiple myeloma, or a similar therapeutic area.

Culture & Benefits

  • Science-driven organization focused on developing life-changing medicines.
  • Opportunity to contribute to a fast-growing organization serving patients worldwide.
  • Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
  • Inclusive workplace and equal employment opportunity commitment.

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