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22 часа назад

Senior Manager, Statistical Programming (SAS)

153 935 - 199 210$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
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
Senior Manager, Statistical Programming (SAS): Leading the production of clinical-trial analysis datasets, tables, listings, and statistical outputs for study reports and regulatory submissions with an accent on clinical programming standards, CDISC requirements, and oncology and cell-therapy studies. Focus on managing programming resources, supervising programmers, resolving study issues, and ensuring high-quality deliverables for regulatory and scientific objectives.

Location: United States – Remote

Salary: $153,935–$199,210 per year, plus potential annual bonus, stock-based incentives, paid time off, and benefits.

Company

hirify.global, a Gilead company, is a biopharmaceutical company developing CAR T-cell and T-cell receptor therapies for cancer treatment.

What you will do

  • Lead statistical programming activities for therapeutic projects and support clinical study deliverables and timelines.
  • Generate or oversee analysis datasets, tables, listings, and statistical outputs for study reports and integrated summaries.
  • Collaborate with Clinical Development, Biometrics, Clinical Data Science, Regulatory Affairs, external vendors, and other cross-functional groups.
  • Plan programming resource needs, allocate capacity, and manage a small team of employees and contractors.
  • Design and code analysis files, maintain documentation, and ensure compliance with departmental procedures and regulatory requirements.
  • Resolve study issues, negotiate timelines, support strategic initiatives, and provide training and technical guidance.

Requirements

  • 8 years of experience with a BS degree in Biostatistics, Computer Science, or an equivalent field; alternatively, 6 years with an MS degree or a PhD with no experience requirement.
  • Experience with clinical and statistical programming processes, clinical trial design, reporting, and regulatory submissions.
  • Extensive experience using SAS, including developing and using SAS macros.
  • Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM, as well as GCP and ICH requirements.
  • Experience leading programming activities, supervising personnel, managing resources, and resolving project issues.
  • Strong communication, interpersonal, analytical, problem-solving, and negotiation skills.

Nice to have

  • Advanced degree in Biostatistics, Computer Science, or an equivalent field.
  • 8 or more years of pharmaceutical or CRO experience.
  • Experience in oncology, hematology, or cell therapy.
  • Experience with pivotal studies and NDA, BLA, or MAA regulatory submissions.

Culture & Benefits

  • Remote work arrangement for the United States.
  • Medical, dental, vision, and life insurance plans for eligible employees.
  • Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
  • People leadership focused on inclusion, talent development, team empowerment, and employee growth.

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