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.
- 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)
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