Regeneron
Regeneron
Regeneron este o companie de biotehnologie care descoperă, dezvoltă și comercializează medicamente pentru afecțiuni grave și insuficient deservite. Cercetările sale acoperă alergiile, bolile cardiovasculare și metabolice, neuroștiința, oncologia, hematologia, oftalmologia și bolile rare. Prin combinarea cercetării biologice cu tehnologia avansată, Regeneron dezvoltă medicamente biologice și genetice concepute pentru a răspunde unor nevoi complexe de sănătate. Compania pune, de asemenea, accent pe echitatea în sănătate, responsabilitatea față de mediu, educația științifică și practicile corporative etice, ca parte a misiunii sale mai ample de a îmbunătăți îngrijirea pacienților.

Principal Biostatistician, Hematology (On-site)

Lead statistical strategy and clinical-trial analysis for Regeneron’s hematology programs. Support regulatory submissions, development decisions, and the advancement of innovative biostatistical methods.

Descriere

  • Partner with cross-functional teams to define drug-development questions and assess endpoint feasibility
  • Develop statistical strategies and design clinical experiments and interventional studies
  • Produce and analyze clinical-trial data to inform interpretation and development decisions
  • Co-author clinical study protocols and statistical analysis plans
  • Conduct statistical analyses for interim and final study reports
  • Create and deliver statistics training for colleagues outside the discipline
  • Help develop new infrastructure, workflows, and processes
  • Contribute to professional associations, conferences, and publications related to pharmaceutical research and regulation
  • Work with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, Medical Writing, and other partners on trial design and analysis
  • Select suitable statistical methods and assess software for planned analyses
  • Coordinate with Statistical Programming on tables, figures, and listings for decisions and regulatory reporting
  • Evaluate clinical-trial and non-trial data for program-level decisions
  • Prepare presentations and written reports for project teams, leadership, and regulatory agencies
  • Present findings jointly to management
  • Research innovative statistical methods and their applications in clinical-trial development

Cerințe

  • PhD or equivalent in statistics, biostatistics, or a related discipline with internship experience, or an MS in statistics or biostatistics plus more than five years of pharmaceutical-industry experience as a statistician
  • Strong leadership and ability to influence stakeholders
  • Proven ability to collaborate across functions
  • Effective performance in a fast-paced, team-oriented environment
  • Demonstrated critical thinking, time management, and communication skills
  • Strong command of statistical analysis methods and experimental and clinical-trial design
  • Proficiency in statistical software such as R or SAS
  • Availability to travel up to 25% may be required

Beneficii

  • Annual bonuses or other incentive programs
  • Equity awards
  • Pension or retirement benefits
  • Company 401(k) matching
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life, and disability insurance
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during recruitment where required

Locuri de muncă similare