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ClickJobs.io ยท 2 days ago
Senior Manager, Biostatistics
Princeton, NJ
Full-time
Hybrid
Senior Level
5+ years exp
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Responsibilities
Serve as the statistical lead on one or more clinical studies in different phases of development
Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculation, authoring of statistical analysis plans, data review, analysis implementation and interpretation
Review of case report forms (CRFs), data management plans, data specifications and clinical study reports, creation of randomization schedules, provide statistical analysis and reports to Data Monitoring Committees (DMCs)
Work with internal staff and/or vendors to assure that all programming and statistical analyses are completed
Provide statistical/programming support for responses to regulatory authorities related to submission reviews
Statistical programming/analyses including transfer, creation, conversion, and formatting of SAS data
Serve as the statistical representative on cross-functional teams
Participate in the development and maintenance of SOPs
Qualification
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Required
PhD in statistics, biostatistics, or related field with 3+ years of clinical development experience; or an MS in statistics, biostatistics, or related field with 5+ years of clinical development experience
Demonstrated understanding of the drug development process
Demonstrated expertise with clinical trial design, study implementation, statistical methodology
Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, macros, analyses and reports
Strong knowledge and experience with sample size software like PASS, NQUERY etc.
Strong communication (oral and written), presentation, and analytical skills
Ability to work independently, prioritize tasks efficiently, and meet expected timelines
Ability to interact collaboratively with colleagues, investigators, key opinion leaders, and regulators
Company
ClickJobs.io
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2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
