Sr. Manager, Biostatistics

Sr. Manager, Biostatistics responsible for providing guidance to statisticians and statistical programmers of Biostatistics in providing the statistical support to clinical development projects, and on assignment basis as needed to other functional areas.

Responsibilities:Provides guidance to statistician and programmers on statistical analysis and programming. Provides statistical input to clinical development protocol and CRF design. Develops and reviews Statistical Analysis Plan, Mock-Up Tables, and Analysis Datasets Specification documents for clinical study protocol. Ensures adherence to project timelines. Develops and administers Biostatistics group budget. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Monitors contract research organization’s (CRO) progress on the adherence of project timelines and the quality of deliverables. Develops detailed project task lists and timelines. Ensures quality of the final statistical analysis results. Tracks progress toward completion of analytical programs, and works with the Sr. Director of Biometrics to adjust resources as necessary to most effectively and efficiently address Biometrics’ priorities. Interfaces with consultants and other functionaries on statistical or data analysis related issues. Responsible for the conduct and quality of assigned statistical analyses. Responsible for implementation of SOPs. Works with Biometrics Management in developing the Biometrics Infrastructure.

Masters/Ph.D. in Statistics, or equivalent with a minimum of 10 years related experience (statistical analysis of pharmaceutical clinical trial results) with a Masters or 8 years related experience with a Ph.D. Generally requires 3 years previous supervisory and managerial experience. Experience with Survival Model preferred.

Must have pharmaceutical experience

Please contact:  Jay VanHousen @ 877-335-8210, ext. 245 / jvanhousen@deltasi.com

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