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 environment to improve the effectiveness of drug development using analytical thinking and therapeutic area knowledge
- Enrich decision making, identify efficiencies, and increase the probability of technical success of projects
- Champion breakthrough approaches using innovative statistical methodology and applications
- Influence the team on critical risks and plans for resolution; integrate information and make data-driven decisions
- Provide input on study protocols, design studies, and write protocols for study conduct
- Select statistical methods, author protocol and statistical analysis plan sections, and conduct analyses
- Collaborate with data sciences on data quality assurance plans
- Maintain currency with statistical methodology and apply and justify new and varied methods
- Perform peer review of work products from statistical colleagues
- Collaborate with team members to write reports and communicate results
- Communicate study results through regulatory submissions, manuscripts, oral presentations, one-on-one customer communication, 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 corporate, medical, local, and departmental policies, procedures, processes, and training
- Introduce and apply innovative methodology and tools to solve critical problems
- Merge 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, such as regulatory submissions
Benefits:
- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
