Biostatistician (Moraga, CA)

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Provides statistical expertise & input to drug dvlpmt prgms, incl the dsgn of translational research / biomarker analysis plans using advanced statistical methodologies. Works closely w/ scientists in translational research &clinical dvlpmt to write study protocols & dsgn experiments, collaborate on biomarker strategy, study dsgn, methodology, data analysis, & interpretation. Provides statistical input into the prep’n of data package to support the filing of New Drug Application (NDA) / Biologics License Application (BLA) to the FDA, & Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Dvlps & reviews statistical analysis plans, incl the definitions of derived variables, the structure & content of analysis datasets, statistical analyese, & the dsgn of templates for statistical tables, figures, & listings for clinical study rports. Guides clinical data mgmt & statistical prgmg members in dvlp’g standards for bldg databases, edit checks, & statistical prgmg specification for data analyses. Monitors project progress & ensures on-time completion. Performs exploratory analysis w/ knowl. Of machine learning & other statistical skills using R & SAS. Reqs Master of Sci. deg. In Biostatistics w/ 6 mths rltd exp. Apply to: Clindata Insight Inc., 533 Moraga Rd, Ste 200, Moraga, CA 94556. Attn: HR.

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