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. or Ph.D. in Statistics or Biostatistics or equivalent with more than 3 Years of relevant experienceOther 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 (ref:biojoby.com)

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