Clinical Project Statistician

Location: CORK (hybrid)

As a Clinical Statistician, you will be a leader in our client’s clinical development programs. You will understand the patient and business needs and then 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. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analysing data for clinical studies.

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.
• 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.
• Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

Minimum Qualification Requirements:

• M.S., Ph.D., in Statistics or Biostatistics

Additional Preferences:

• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc
• Technical expertise and application with working knowledge of experimental design and statistical analysis
• Business process expertise associated with critical activities (e.g., regulatory submissions)