Purpose
- The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. Responsible for establishing a reporting database and analyzing data for clinical studies.
Primary Responsibilities
- Provide input on study protocols and design studies; write protocols for study conduct.
- Select statistical methods for data analysis; author protocol and statistical analysis plan sections; conduct analyses once a reporting database is created.
- Collaborate with data sciences to plan and implement data quality assurance.
- Maintain current knowledge of statistical methodology; justify chosen methods.
- Perform peer review of work products.
- Influence team members on appropriate research methods.
- Collaborate to write reports and communicate results.
- Communicate study results via regulatory submissions, manuscripts, and/or oral presentations; present one-on-one with key customers and at scientific meetings.
- Respond to regulatory queries and interact with regulators.
- Understand disease states, competitive landscapes, and regulatory environment.
- Work in full compliance with assigned curriculum(s) and follow applicable policies, procedures, processes, and training.
- Introduce innovative methodology/tools; merge scientific thinking with business knowledge; lead projects independently across functions.
Minimum Qualification Requirements
- Ph.D. in Statistics OR Biostatistics with at least 2 years of experience in Clinical Research and Development.
Preferred/Additional Skills
- Proficient in statistical programming languages/software (e.g., SAS, R, Spotfire, WinBUGs).
- Interpersonal communication skills; teamwork/leadership; experimental design and statistical analysis knowledge; self-management; resource management; creativity/innovation; problem solving/critical thinking.
Benefits (as stated)
- Eligible for company bonus; comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).