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
