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4 дня назад

FSP Principal Biostatistician, Medical Affairs

111 000 - 309 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Canada
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
FSP Principal Biostatistician, Medical Affairs (Clinical Trials/Statistical Programming): Providing statistical analysis support for Phase 2 and 3 pharmaceutical clinical trials with an accent on statistical analysis plans, efficacy and safety analyses, and regulatory standards. Focus on programming and validating outputs in SAS or R, interpreting study results, guiding programmers, and applying CDISC standards.

Location: Home-based in the United States or Canada

Salary: $111,000–$309,000 annualized base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Provide statistical analysis support for Phase 2 and 3 pharmaceutical clinical trials.
  • Establish project objectives and timelines with multidisciplinary teams.
  • Author statistical analysis plans and contribute to publications and presentations.
  • Provide statistical expertise to Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations teams.
  • Program or validate tables, listings, and figures using SAS or R.
  • Interpret study results, review reports, support exploratory analyses, and guide programmers.

Requirements

  • PhD in Statistics, Biostatistics, or a related field with 5+ years of industry experience, or MS with 7+ years of industry experience.
  • At least 3 years of Phase 2/3 clinical trial experience.
  • Ability to perform efficacy and safety analyses and validate important data derivations using R or SAS.
  • Experience with CDISC, including SDTM, ADaM, and CDASH.
  • Understanding of ICH GCP, ICH E9, and general industry practices and standards.
  • Ability to work independently, communicate effectively, and manage programmers constructively.

Nice to have

  • Experience contributing to peer-reviewed publications and presentations.

Culture & Benefits

  • Home-based remote work with flexible schedules and a focus on work-life balance.
  • Collaboration with statistical, research, and sponsor teams.
  • Technical training and a tailored development curriculum.
  • Research opportunities aligned with individual expertise.
  • Long-term engagements, redeployment opportunities, and a career development path.
  • Experience supporting regulatory submissions and bringing new therapies to market.

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