Clinical Statistical Programmer - Pharma

The purpose of the Clinical Statistical Analyst is to assist during the development of data analysis plans in collaboration with statistical colleagues, physicians, veterinarians, and/or medical colleagues. The Clinical Statistical Analyst is responsible for establishing are porting database and for analyzing clinical trial data by working with clinical research associates/clinical development associates and project statisticians.

Key Responsibilities :

- The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.

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, 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 proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.

- Effectively justify methods selected and implement previously outlined analysis plans.

- Conduct peer-review of work products from statistical colleagues.

- 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.

- 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 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.

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