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4 часа назад

Biostatistical Programming Manager

130 000 - 140 000$
Тип работы
fulltime
Грейд
senior
Английский
c1
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
Biostatistical Programming Manager (SAS/Clinical Trials): Providing strategic oversight and hands-on statistical programming for clinical trial deliverables, with an accent on SDTM, ADaM, TFLs, regulatory submissions, and quality oversight. Focus on leading urgent programming projects, validating outsourced and internal deliverables, troubleshooting at-risk studies, and supporting obesity development programs.

Location: Washington D.C., District of Columbia, United States

Salary: $130,000–$140,000 annual salary, plus eligible total rewards and bonus opportunities.

Company

hirify.global is a biotechnology company developing and manufacturing medicines across oncology, inflammation, general medicine, and rare disease, with this role supporting the obesity therapeutic area.

What you will do

  • Provide rapid-response statistical programming support for urgent internal and external requests.
  • Lead programming for studies and special projects, including Data Access Plan activities and unblinding efforts.
  • Develop and support SDTM, ADaM, Tables, Listings, Figures, and regulatory submission deliverables.
  • Oversee outsourced and in-house programming deliverables for quality, compliance, timelines, and productivity.
  • Mitigate at-risk projects through technical expertise, hands-on programming, and operational guidance.
  • Contribute to training, continuous improvement, inspection readiness, innovation, metrics, and documentation reviews.

Requirements

  • Doctorate degree; or a master’s degree with 2 years of statistical programming experience; or a bachelor’s degree with 4 years; or equivalent experience based on the stated education pathways.
  • At least 6 years of statistical programming experience in the biopharmaceutical industry and regulatory submission experience.
  • Strong hands-on SAS expertise, including Base SAS, Macro, SQL, SAS/Graph, and statistical packages.
  • Experience developing and validating SDTM and ADaM datasets and TFLs, with a strong understanding of clinical trial processes and data standards.
  • Experience providing quality oversight for outsourced and internal programming deliverables and troubleshooting complex technical issues.
  • Excellent oral and written English communication skills required.

Nice to have

  • Master’s degree in statistics, mathematics, computer science, life sciences, or a related scientific field.
  • Experience with R for clinical trial analyses, data manipulation, reporting, and visualization.
  • Familiarity with Python and other programming tools.
  • Experience supporting obesity clinical development programs, including obesity endpoints, data standards, and regulatory considerations.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Comprehensive employee benefits, including medical, dental, vision, life, disability, and flexible spending plans.
  • Retirement and savings plan with company contributions and stock-based long-term incentives.
  • Discretionary annual bonus program and award-winning time-off plans.
  • Flexible work models where applicable to the specific work location.

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