Director – Statistics

Job Description:

  • Lead development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level
  • Shape the internal and external drug-development environment using analytical thinking and therapeutic-area knowledge
  • Enrich decision-making, identify efficiencies, and increase projects’ probability of technical success
  • Champion innovative statistical methodology and applications
  • Influence teams on critical risks and plan resolutions; integrate information and make data-driven decisions
  • Provide input on study protocols, design studies, and write study-conduct protocols
  • Select statistical methods, author protocol and statistical analysis plan sections, and conduct analyses after database creation
  • Collaborate with data sciences on data quality assurance plans
  • Maintain current knowledge and proficiency in statistical methodology and justify selected methods
  • Peer-review statistical colleagues’ work products
  • Influence team members regarding appropriate research methods
  • Collaborate on reports and communicate study results
  • Communicate results through regulatory submissions, manuscripts, oral presentations, customer discussions, and scientific meetings
  • Respond to regulatory queries and interact with regulators
  • Understand disease states, competitive landscapes, and regulatory environments
  • Perform work in compliance with applicable policies, procedures, processes, and training
  • Introduce and apply innovative methodology and tools to solve critical problems
  • Combine scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions
  • Lead projects independently and work effectively across functions
  • Apply technical expertise to influence business decisions

Requirements:

  • Ph.D. in Statistics OR Biostatistics
  • At least 7 years of experience in clinical research and development in the Pharmaceutical Industry
  • Significant experience with clinical trials, medical research, and/or real-world evidence
  • An established track record of developing and maintaining an area of statistical or collaborative research
  • Proficient in statistical programming languages/software such as SAS, R, Spotfire, etc
  • Interpersonal communication skills for effective customer consultation and collaboration
  • Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions
  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables
  • Resource management skills
  • Creativity and innovation
  • Demonstrated problem solving ability and critical thinking
  • Business process expertise associated with critical activities (e.g., regulatory submissions)
  • Ability to follow applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training

Benefits:

  • Company bonus depending partly on company and individual performance
  • Company-sponsored 401(k)
  • Pension
  • Vacation benefits
  • Medical benefits
  • Dental benefits
  • Vision benefits
  • Prescription drug benefits
  • Healthcare and/or dependent day care flexible spending accounts
  • Life insurance and death benefits
  • Time off and leave of absence benefits
  • Employee assistance program
  • Fitness benefits
  • Employee clubs and activities
  • Disability accommodation support during the application process
  • Employee resource groups
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