Job Category: Clinical & Statistics

Contract Senior Biostatistician

Job Location: N/A

Contract Senior Biostatistician

Pharmaceutical / Biotech, North NJ

1 year renewable contract, corp to corp or W2, several openings

Rate varies based on experience and job


Description:

Work closely with clinicians, programmers, and publication managers to generate outputs for publications, review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies, coordinate internal resource utilization for publication and generate activities metrics for management review. Work with the clinical study team on study design, development and or review of clinical study protocols. Develop and or review statistical analysis plans, including Table’s, listing’s, figure shells and final study reports for clinical studies, perform statistical analyses as needed. Work with the project statistician and clinical data managers on design and review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT), generate, review data tables, listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables. May work on submission teams as a statistician and/or a programmer. Act as lead Statistician on complex trials and across multiple studies. Act as a lead representative of the of the biostatistics department on project teams.


Requirements:

Must have a MS in Statistics with at least 6 years of experience or a PhD in Statistics with at least 4 years of experience in the pharmaceutical, Biotech or CRO industries. Strong SAS programming skills. Minimum 4 years. Good technical writing skills. Good communication skills (verbal and written). Strong teamwork ability, commitment and individual initiative. Strong organizational skills with ability to effectively manage multiple projects.


Please contact Darren Gutowski at dgutowski@clarkdavis.com


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