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As The Director, Statistical Programming, you will be a champion of Otsuka's culture and values and serve in a leadership role within the Statistical Programming group. Serve as the in-house expert and key advisor to head of the Statistical Programming group on the programming strategy by providing assessment of state-of-art and industry trends in ways of working, efficient coding such as macro library and utility macros, and technology.
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Knowledge of statistics, data sciences and experience using statistical packages for analyzing datasets (SAS, R, R-Shiny etc.) Knowledge of statistics, data sciences and experience using statistical packages for analyzing datasets (SAS, R, R-Shiny etc.
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Provide functional expertise and leadership to statistical programming and data science colleagues while delivering comprehensive programming expertise to clinical project teams in support of development, regulatory approval, and market acceptance of company’s products.
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Associate Director, Statistical Programming, provides functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products.
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Lean manufacturing/six sigma/statistical analysis ; Six Sigma Green Belt a plus. As a member of UDC’s Chemical Business, this position will work closely with UDC’s HQ team, UDC’s contract manufacturing partner (PPG), and other UDC subsidiaries in the development and manufacture of UDC’s OLED materials in a fast-paced, non-GMP environment.
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The position will be a key partner to the Head of Biostats in Cell Therapy and will assists their teams to ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for an indication/disease area.
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Programming Skills - knowledge of statistical programming languages like R, Python, and database query languages like SQL, Hive, Pig is desirable. Programming Skills - knowledge of statistical programming languages like R, Python, and database query languages like SQL, Hive, Pig is desirable.
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The (Associate) Director of Biostatistics acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below.
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Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed. Senior Statistical Programmer. Knowledge of and ability to learn relevant clinical background and biomarker biology and incorporate these into statistical design, analysis & interpretation.
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Leads statistical programming efforts for BLA, MAA and other regulatory submissions, including SDTM and ADaM datasets and associated define files, tables/figures/listings for integrated summaries (ISS and ISE), etc.
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Minimum 12 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with excellent knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines and proven experience in the development of processes/tools.
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Such projects may involve performing fate and transport modeling (including groundwater flow, vapor intrusion, air emission and dispersion, and surface water); statistical analysis; spatial analysis; developing remediation/risk management plans; and providing technical support for litigation and regulatory negotiations.
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Your duties will encompass coordinating process development initiatives, supervising pilot batches in compliance with cGMPs, establishing project objectives and schedules, and conducting in-depth data analysis using statistical methodologies.
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Six months of experience in performing data analysis using statistical computing environments and tools (e.g. SAS, R, SPSS, Python) is required. Perform statistical analysis and data processing tasks that require an understanding of statistics and measurement (e.g., multiple regression, reliability, validity) by using ETS proprietary software, Excel, and statistical software packages such as SAS.
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Leading and managing team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development.
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statistical job in Princeton, NJ
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