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| Job Description |
| Job Title | Biostatistician |
| Requirement ID | 41939 |
| Begin Date | 8/5/09 |
| Duration | |
| Location | Bothell, WA 98021 |
| Other Location | |
| Description | If you are looking for a stimulating environment where discovery and development of therapies to treat cancer patients is the central goal, we are 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. |
| Required Skills | 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 |
