Department: Clinical

Job Title: Contract Senior Biostatistician

Job Location: Seattle, WA

Requisition #: T2011A1BC

Description:

This is a 6 month contract with the possibility of extension. This position is responsible for all statistical aspects of individual clinical trials including clinical trial design/planning, statistical analysis plan, and interpretation/reporting of trial results. He or she represents the Biostatistics team on the study team, and ensures timeliness and adequate quality of all Biostatistics deliverables.  This position is responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence.  Examples of these tasks include clinical trial design/planning, statistical analysis plan, data interpretation/reporting, exploratory analyses and additional analyses to support publications, and statistical consultation throughout the lifetime of the clinical trial.  Tracking clinical trial activities and milestones.  Collaborating with SAS programmers to ensure timelines are met and to ensure adequate quality of all Biostatistics deliverables for the assigned trials.  Must follow CTI SOPs, TGIs, as well as Health Authority requirements (e.g., GCP, regulatory guidelines).  Establish and maintain sound working relationships and effective communication with the clinical study team. Participate in non-clinical projects (initiatives, process teams etc.) as needed.

Job Requirements:

Requires Master's degree with a minimum of 5 years experience. Pharmaceutical experience required. PhD in Biostatistics/Statistics preferred.  Desired experience includes:  Directing SAS programmers, regulatory filing experience, and experience with oncology clinical trials.  Requires an in depth knowledge of biostatistics, particularly clinical trial design and analysis is required. Knowledge of the requirements and guidelines for FDA submissions.

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