argenx

Biostatistics Director – Indication Lead, Myasthenia Gravis

argenx

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • Serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets)
  • Drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for
  • Drive quantitative data strategy of the indication you are responsible for
  • Collaborate with stakeholders and lead delivery of all statistical deliverables
  • Oversee delivery of all statistical deliverables for the indication you are responsible for and contribute to HA submissions
  • Report to a franchise team leader, within the Biostatistics and Modeling organization
  • Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
  • Guide the team of statisticians supporting the different assets

Requirements

  • Master or doctorate (Ph.D.) degree in Statistics or related field
  • At least 7 years of experience in biotech/pharma industry
  • Proven record of leading statistical activities, including dossier submission and major agency interactions involving BLA/NDA/MAA (pre and post dossier submission)
  • Expertise in drug development
  • Experience driving complex innovative designs or cutting-edge methods
  • Advanced knowledge of biostatistics and a strong command of its application to clinical trials
  • Proficient in statistical software (SAS and/or R)
  • Ability to collaborate with program partners and stakeholders to deliver on the statistical deliverables
  • Ability to clearly explain complex statistical concepts in written and spoken English
  • Team player with a focused attitude
  • Ability to work autonomously as part of a cross-disciplinary team in a dynamic environment of a fast-growing biotech company with challenging timelines
  • Ability to motivate and empower statisticians supporting you
Benefits
  • Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
  • A work-environment in a human-sized, dynamic, rapidly growing biotech company
  • Competitive salary with extensive benefits
  • Chance to grow and be a part of a team driven by creativity, innovation and science
  • Eligibility to participate in short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies
  • Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
biostatisticsstatistical activitiesdrug developmentinnovative designsclinical trialsSASRdossier submissionBLANDA
Soft Skills
collaborationcommunicationteam playerautonomyleadershipmotivationempowermentfocused attitudeexplanation of complex conceptscross-disciplinary teamwork
Certifications
Master's degreePh.D.