Job Description

Bio Statistician

- 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.

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