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
