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The Senior Director of Real-World Evidence Biostatistics plays a pivotal role in leading and overseeing the strategic direction and execution of statistical and real-world evidence initiatives within the organization.
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Interaction: This role interacts with numerous teams, including health economic and outcome research, market access, commercial operations and strategy, payer and employer relations, business development and clinical trials, data and statistical programmers, biostatisticians, project management, IT and external vendors.
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Demonstrated expertise in statistical programming including CDISC standards and CDISC compliant submission requirements. Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and AbbVie values.
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Expertise in Statistical Process Control (SPC), Total Quality Management (TQM), Failure Mode & Effects Analysis (FMEA), 8D report and Minitab statistical software. Experience and/or certification in Lean Six Sigma (Green Belt) is preferred.
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Statistical Analysis: The data scientist possesses a strong foundation in statistics, understanding concepts like hypothesis testing, regression analysis, probability theory, and statistical modeling techniques.
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Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV’d) and to Biostatistics on Statistical Analysis Plan (SAP). Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.
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Understanding of technical areas related to pharmaceutical, biological, and/or cell therapy manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes, validation and qualification requirements, etc.
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Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed.
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ACI/NICET/NJ DCA Special Inspector and Nuclear Densometer certification a plusValid Driver"s License and possess reliable transportation to access job sitesAble to work with mathematical concepts such as probability and statistical inference, and fundamentals of solid geometry and trigonometry.
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40-hour OSHA HAZWOPER certification Engineer in Training (EIT) preferred or have the ability to become registered within six months. Proficient or familiarity with AutoCAD, Autodesk Civil 3D, NitroPro, GSLOPE, KeyWall, MS Word, Excel, Adobe.
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Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming, and other stakeholders. Review Protocols, statistical analysis plans, and statistical programming plans.
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Strong proficiency in statistical analysis and modeling techniques, such as linear regression, logistic regression, decision trees, random forests, clustering, deep learning algorithms, boosting, text mining and NLP.
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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). Provides statistical programming support and related training to teams, department, partnering functions, and collaborators.
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Building on the pioneering research of founders Bruce Jacobs and Ken Levy, the firm has developed a unique, multidimensional, dynamic approach to investing that combines human insight and intuition, finance and behavioral theory, leading-edge quantitative and statistical methods, and over 35 years of proprietary research.
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The Data Analyst will provide analysis of VA electronic medical record data (e.g., CDW), presentation of statistical findings that are consistent with VA, VHA, and EXPRT/WRIISC strategic plans, policies, regulations, style guides, and publication standards, administrative support for research and evaluation protocols, and qualitative research support consistent with policies, regulations, style guides, and publication standards.
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statistical job in Florham Park, NJ
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