Sr. Biostatistician
SimulStat
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*12 month renewable contract
* Hybrid work schedule – must be located in NJ and able to come onsite to Short Hills office up to 1 day per week.
Responsibilities
• Authoring, updating statistical analysis plans Creating mock table shells
• Creating data simulations for study design issues
• QC’ng / documenting detailed SAS code to execute efficacy analysis (e.g., data imputation techniques)
• Coordinating clinical team comments for analysis requests
Requirements
• PhD or Master’s degree in statistics or biostatistics, or a related discipline
• 4+ years of experience in the design, analysis, and reporting of clinical trials studies (Phase I, II, III) for a pharma or biotech company
• Strong organizational skills and proven ability to effectively lead a project to successful completion
• Significant expertise in the design, analysis, and reporting of clinical studies
• Advanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Expertise in interacting directly with regulatory authorities highly desirable
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