The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans for immunology early clinical development 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.
- 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 immunology 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.
The Project Statistician at this level provides statistical leadership in multiple dimensions including:
- Introduces and applies innovative methodology and tools to solve critical problems
- Merges scientific thinking & business knowledge to identify & impact business issues.
- Drives projects internally (or externally), and works effectively across functions. Uses technical expertise to influence business decisions.
- Identifies broad technical issues, drives assessment of options and implements robust solutions.
- Has broad understanding of regulatory environment; demonstrates leadership on regulatory issues.
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- Ph.D. in Statistics or Biostatistics
- At least one manuscript submitted or published in a peer-reviewed journal
- At least one oral presentation at a statistical conference
- Interpersonal communication skills for effective customer consultation
- Teamwork and leadership skills
- Technical growth and application with working knowledge of experimental design (including adaptive designs) 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)