If you are looking for a stimulating environment where discovery and development of therapies to treat cancer patients is the central goal, Seattle Genetics is interested in hearing from you! We are looking for a highly motivated individual to join our team as our Biostatistician to provide statistical support for clinical trials.


MAJOR DUTIES & RESPONSIBILITIES:
- Perform sample size and power calculations
- Review CRFs and edit checks
- Assist in developing SAP and create table, listing, and figure shells
- Validate statistical analysis as defined in SAP
- Able to code statistical analyses as needed familiar with good coding practices
- Provide biostatistics support for study teams
- Assist in interpretation and writing of results
- Support preparations for interactions with regulatory agencies
- Assist in regulatory submissions
- Read and understand Medical/Clinical literature as required by duties
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
- Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

REQUIREMENTS: 
- At least two years in pharmaceutical/biotechnology clinical trials or related environment

- Masters level in Statistics, Epidemiology or related field

- Knowledge of SAS a must; knowledge of R/S-Plus a bonus

- Knowledge of GCP, ICH and other regulatory guidelines

- Able to prioritize work and complete deliverables to timelines with some supervision

- Excellent verbal and written communication skills

- Detail and process oriented

Please click HERE to apply