Clinical Project Statistician
Life Science Recruitment
- Cork
- Permanent
- Full-time
Our client, a global pharma company, are continuing to grow their Statistics team and are currently recruiting for a Clinical Project Statistician to join their team on a permanent basis. As Clinical Project Statistician, you will develop or assist in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and/or medical colleagues. You will be responsible for working with research associates and scientists to establish a reporting database and for analyzing data for clinical studies. This is a great opportunity to join a very talented team. This role also offers hybrid working.Responsibilities
- 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
- Collaborate with team members to write reports and communicate results
- Communicate 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
- Ph.D., or equivalent or, M.S. with experience
- Statistics, Biostatistics, or equivalent of field study
- 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
- Business process expertise associated with critical activities (e.g., regulatory submissions)