Remote Otter LogoRemoteOtter

Director of Biostatistics - Remote

Posted 5 days ago
All others
Full Time
USA
$212,500 - $262,500 USD/year

Overview

The Director of Biostatistics acts as program statistical lead providing technical leadership and biostatistical support on the design and conduct of clinical studies, ensuring statistical integrity and contributing to regulatory submissions.

In Short

  • Lead statistical support for clinical studies
  • Contribute to regulatory interactions and filings
  • Ensure statistical integrity of deliverables
  • Mentor junior team members
  • Develop statistical methodologies
  • Collaborate with cross-functional teams
  • Conduct analyses and propose new methodologies
  • Author regulatory documents and scientific publications
  • Manage project milestones and requirements
  • Participate in study-related meetings

Requirements

  • PhD in Statistics or Biostatistics with 8+ years of experience
  • Experience in NDA/BLA/MAA activities
  • Strong understanding of ICH guidelines and regulatory authority guidance
  • Experience with SAS and R
  • Detail-oriented with strong organizational skills
  • Familiarity with CDISC standards
  • Ability to prioritize tasks effectively
  • Experience in clinical trial settings
  • Proven ability to manage multiple projects
  • Strong problem-solving skills

Benefits

  • Generous vacation time and public holidays
  • Volunteer days
  • Long-term incentives and employee stock purchase plans
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans
Ultragenyx Pharmaceutical logo

Ultragenyx Pharmaceutical

Ultragenyx Pharmaceutical Inc. is a pioneering biopharmaceutical company dedicated to transforming the landscape of rare disease medicine. With a commitment to patient care, Ultragenyx challenges conventional approaches by developing innovative treatments that are accessible and affordable. The company fosters a collaborative and inclusive culture, emphasizing the growth and well-being of its employees. Ultragenyx aims to create a supportive environment where individuals can thrive both professionally and personally, ultimately striving to make a meaningful impact in the lives of patients and their families.

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