Description:
The purpose of the Clinical Statistical Analyst is to assist during the development of data analysis plans in collaboration with statistical colleagues, physicians, clinical research scientists, and/or medical colleagues. The Clinical Statistical Analyst is responsible for establishing a reporting database and analyzing clinical trial data by working with clinical research associates/clinical data associates and project statisticians.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Statistical Trial Analysis
- Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
- Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, creating the reporting database, and conducting the actual analysis once a reporting database is created.
- Collaborate with data sciences in the planning and implementation of data quality assurance plans.
- Effectively justify methods selected and implement previously outlined analysis plans.
- Conduct peer-review of work products from statistical colleagues.
- Maintain proficiency with respect to statistical programming and statistical methodology and in applying new and varied methods.
- Maintain current knowledge of CDISC data standards.
- Effectively utilize current technologies and available tools for conducting the clinical trial analysis.
Communication of Results and Inferences
- Collaborate with other statistical colleagues to write reports and communicate results.
- Be responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers.
- Assist or respond to regulatory queries working in collaboration with other statistical colleagues
Therapeutic Area and Systems Knowledge
- Understand relevant disease states and competitive landscapes in order to enhance the level of customer focus and collaboration.
- Ensure replication of tools and systems, where applicable, and stay informed of technology advances.
Minimum Qualification Requirements:
- M.S., Ph.D., or equivalent experience
- Statistics, Biostatistics, Computer Science field study or equivalent
- 2-3 years experience in the pharmaceutical industry