
Clinical Project Statistician
- Cork
- Permanent
- Full-time
- 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.
- Perform peer-review of work products from other statistical colleagues.
- Influence team members regarding appropriate research methods
- 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.
- 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.
- 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.
- 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.
- M.S., Ph.D., in Statistics or Biostatistics
- Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc
- Interpersonal communication skills for effective customer consultation
- Teamwork and leadership skills
- Technical expertise and application with working knowledge of experimental design and statistical analysis
- 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)