Job Description

Participates in the design of clinical trials and research projects, and the analysis and interpretation of data.

Participates in the investigational process from initiation to closing

Participates in the development and review process of SOP's

Develops statistical analysis plans, mock tables, programming and tables specifications

Produces Tables, Listings and Figures (TLF's) and performs data review and statistical analysis

Assists in protocol development, sample size calculations, and case report form (CRF) review

Advises data management staff on database design, validation checks and critical data

Develops study specific randomization schedules

Offers support on a variety of statistical issues

Communicates with the Sponsor and/or site representatives

Reports, reviews and codes adverse events (including serious and non-serious)

Organizes workflow in compliance with timelines

Participates in department and project audits


Experience in the CRO and Pharmaceutical industries

MS Office

Medical Terminology with MedDRA

Experience with SAS, SPSS etc.

Knowledge of 21 CFR Part 11


A minimum of a Bachelor's degree

Experience with statistical analysis and/or clinical research

Job Requirements