Contact: Lauren Scutero – lscutero@penfieldsearch.com
Purpose:
The Project Statistician at the Research Scientist level provides statistical leadership in multiple dimensions including:
- Provides technical leadership and expertise in initiating and executing multi-disciplinary or cross functional projects that impact the Lilly Research Laboratory and the Statistical Sciences organization;
- Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice;
- Leads the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues;
- Provides consulting and statistical direction on priority clinical projects.
Key Responsibilities:
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.
Statistical Trial Design and Analysis
- Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
- Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.
- Collaborate with data sciences in the planning and implementation of data quality assurance plans.
- Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
- Influence team members regarding appropriate research methods
- Perform peer-review of work products from other statistical colleagues.
Communication of Results and Inferences
- Collaborate with team members to write reports and communicate results.
- Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
- Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
- Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
- Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Statistical leadership and Teamwork
- 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.
Basic Qualifications:
- Ph.D. in Statistics OR Biostatistics
- 5 - 7 years of proven experience in clinical research and development
Additional Skills/Preferences:
- Significant experience with clinical trials, medical research, and/or real-world evidence
- Technical expertise and application with working knowledge of experimental design and statistical analysis
- 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, WinBUG, etc
- Demonstrated problem solving ability and critical thinking
- Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.
- Interpersonal communication skills for effective customer consultation and collaboration
- Creativity and innovation
- Business process expertise associated with critical activities (e.g. regulatory submissions)
