Senior Biostatistician Job in King Of Prussia 19406, Pennsylvania US


job ID: 8318

Position Title: Senior Biostatistician

Working Location: US, Any INC Office

Employment Status: Full-Time Regular

Required Experience: 2 years

Required Education: Masters Degree

Required Travel: 0

Job Summary:
This position would ideally be based in North Carolina (Raleigh Wilmington) or King of Prussia, PA.

Works independently on clinical trial projects sponsored by pharmaceutical, biotechnology, or medical device companies. Explains, interprets, utilizes complex statistical procedures. Works closely with project managers, database managers, and clinical data managers, and participates as a project team member. Discusses statistical aspects of studies with investigators. May estimate resources and timelines in the proposed process.
Core Responsibilities:
1. Leads the planning and implementation of statistical analysis for clinical study reports and regulatory dossiers. 2. Represents company at internal and sponsor technical meetings. 3. Utilizes advanced statistical methods (interim analysis stopping rules, analysis of pharmacokinetic parameters, logistic regression etc.). 4. Ensures that all work is accomplished on time and according to established process and seeks continuous improvement of the process. 5. Employs knowledge of SAS statistical programming technique as applied to clinical trials, while keeping up-to-date on developing SAS procedures. 6. Writes statistical sections for protocols, protocol analysis plans, mock tables shells and finalizes clinical/statistical integrated reports. 7. Maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, attending professional meetings, etc. Performs other work related duties as assigned. Minimal travel may be required (up to 25%).

Skills Attributes:
Requires Ph.D. in Biostatistics/Mathematical Statistics plus nominal experience in a contract research organization (CRO), biotechnology or pharmaceutical environment; or a M.S. in Biostatistics/Mathematical Statistics with more relevant CRO, biotechnology or pharmaceutical experience. Requires extensive use of independent judgment. Strong SAS programming skills and experience in UNIX or personal computer environment are essential. Strong computer skills in Microsoft Office Suite are necessary. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, presentation, documentation and interpersonal skills as well as a team-oriented approach.

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