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10 дней назад

Associate Director, Programming (Biopharma)

164 000 - 213 000$
Формат работы
remote (Global)
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, Programming (Biopharma): Leading statistical programming for clinical development compounds and studies with an accent on programming strategy, regulatory submissions, and CDISC-compliant deliverables. Focus on providing hands-on R and SAS programming, managing multiple studies, improving processes, and guiding programmers, contractors, and vendors.

Location: Fully remote; can be performed from anywhere. Occasional travel of approximately 15% for team meetings or events is expected. Company location: Bridgewater, New Jersey, US.

Salary: $164,000–$213,000 annual.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Lead programming activities and provide technical leadership as Program Lead Programmer for an assigned compound and related studies.
  • Act as Study Lead Programmer for one or more studies and set programming strategy, priorities, tasks, and resources.
  • Provide hands-on programming support for studies, exploratory analyses, and regulatory agencies’ ad-hoc requests.
  • Ensure quality, timeliness, analysis and reporting standards, regulatory compliance, SOPs, and Work Instructions.
  • Lead process improvement initiatives and contribute to internal standards for programming tools, outputs, and macros.
  • Guide hirify.global programmers, contractors, and vendors; review or author SOPs and Work Instructions.

Requirements

  • Master’s degree in Biostatistics, Statistics, Computer Science, Data Science, or a related field and 6 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development; OR a bachelor’s degree in one of these fields and 10 years of relevant experience.
  • Proficiency in R, with familiarity with the pharmaverse and tidyverse ecosystems for clinical data analysis and reporting.
  • Significant knowledge of drug development, clinical trial methodology, and regulatory requirements for drug approval.
  • Experience with global regulatory submissions.
  • Extensive knowledge of CDISC standards, including SDTM and ADaM dataset specifications and define.xml.
  • Experience managing multiple studies within a program in a fast-paced environment and experience in project management.
  • Experience with SAS.
  • Ability to adapt to changing organizational needs and work effectively independently and in cross-functional teams.
  • Excellent verbal and written communication, organization, attention to detail, clarity, accuracy, proactive problem-solving, resourcefulness, and sound decision-making.

Nice to have

  • Experience with Python.
  • R package development experience.

Culture & Benefits

  • Fully remote work with connection to the hirify.global team and community, flexible work schedules, and purposeful in-person collaboration.
  • Medical, dental, vision, and mental health support, wellbeing reimbursement, and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, and caregiver support.
  • 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, LinkedIn Learning, workshops, leadership programs, mentorship, employee resource groups, and service opportunities.

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