BioSpace · 6 hours ago

Manager, Evidence Generation Biostatistics

United States

Full-time

Remote

Mid Level

4+ years exp

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Comp. & Benefits

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Responsibilities

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.

Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.

CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.

Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities

Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

Qualification

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StatisticsBiostatisticsStatistical AnalysisDrug DevelopmentCRO OversightResults InterpretationStatistical MethodologyStatistical ProgrammingMaster's Degree in StatisticsPharmaceutical Industry Experience