Senior Biostatistician

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. Based on current business needs, the application of these tasks may vary.

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 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)

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