- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Programmer leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical ... projects.- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disordersSummaryProvide strategic leadership for all statistical programming activity related to study, project and submissionManage CRO ... global harmonization of programming processes supporting global submissionResponsibilities - Statistical Programming Management: Coordinates outsourced statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO ... of global harmonization of programming processes supporting global submission.Responsibilities- Statistical Programming Management: Coordinates outsourced statistical programming… more
- Merck & Co. (Rahway, NJ)
- …set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose predominant accountability ... including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the statistical ...and Statistical Programming to plan for the statistical analysis and reporting of clinical drug and vaccine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, ... perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary… more
- Merck & Co. (North Wales, PA)
- …benefit of patients and global human health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. ... projects.-- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (North Wales, PA)
- …experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, ... electronic submission deliverables.Designs and develops complex programming algorithms.Familiarity with statistical analysis methods, terminology and concepts.Superior experience as a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Matter Expert for AI/ML by providing guidance and support to Data and Statistical Science team members as well as represent the department in cross-functional teams- ... Responsible for monitoring and applying regulatory guidance and industry best practices- Demonstrates leadership within AI/ML by partnering with internal and external stakeholders to optimize technology, processes, and standards (improving quality/inspection… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …of all new clinical studies.The Director will support Integrated Data Analytics and Statistical Programming in statistical analysis and oversee statistical ... skills to provide direct line management to regular and contract statistical programmers. Essential FunctionsOversee Clinical Analysis Reporting Leads for delivery… more
- Merck & Co. (North Wales, PA)
- …under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other of our company's Research ... in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.The incumbent may initially work in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position will have strong knowledge ... of major statistical methods within industry standards including proficiency on handling statistical software such as but not limited to SAS and R. The position… more
- Eisai, Inc (Nutley, NJ)
- …Global Value & Access (GV&A) team, responsible for leading and overseeing statistical activities across a diverse portfolio. This portfolio includes studies related ... timelines.Responsibilities include, but are not limited to, serving as the statistical lead on project teams. This involves providing valuable statistical… more
- Eisai, Inc (Nutley, NJ)
- …be expected to work independently with minimal supervision, serving as the statistical lead in support of collaborations led by Translational Science to evaluate ... as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual primarily will be accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of ... optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This position… more
- Insmed Incorporated (Bridgewater, NJ)
- …role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development ... process. This role provides statistical input into the drug development plan, researches and...into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position ... (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical ... TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …minimal supervision to solve complex project problems.Responsibilities- Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results ... Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire...very complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project… more
- Mindlance (Atlanta, GA)
- …regulatory agencies. Mentors others in the application of more complex statistical . methodologies. Performs project management functions relating to the ... of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including… more
- Mindlance (Atlanta, GA)
- Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills: 1) Biostatistics, Statistical Analysis Plans 2) SAS Programming 3) ADAM Data Sets 4) FDA ... as a subject matter expert and lead in providing statistical , process and regulatory knowledge to the department. Acts...complex studies. Acts as a project manager, overseeing the statistical and programming aspects of clinical trials from design,… more
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