Job Description

Purpose:

• The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues.
• The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.



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 conducting the actual analysis once a reporting database is created.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
• Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
• Participate in peer-review 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 to interact with regulators.

Therapeutic Area Knowledge

• Understand disease states 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.

Minimum Qualification Requirements:

• M.S., Ph.D., or equivalent experience

Other Information/Additional Preferences:

• Statistics, Biostatistics, or equivalent of field study
• Proficient in the SAS programming language
• Interpersonal communication skills for effective customer consultation
• Teamwork and leadership skills
• Technical growth and application with working knowledge of experimental design and statistics
• 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 strategic thinking
• Business process expertise associated with critical activities (e.g. regulatory submissions)