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