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Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience. Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
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Experience with programming in SAS, R and other statistical software and working with various database structures are crucial components of this position. This position involves project management for the statistical analyses and programming of clinical trials from small investigator initiated studies to large scale international clinical trials.
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Experience with one or more programming languages for data analysis, such as R, Python, SAS, SPSS, Stata. Collect, clean, and analyze data from disparate sources, including City departments, the Commonwealth of Massachusetts, and Federal statistical agencies, particularly the Census Bureau.
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Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming support.
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Managing the technical assistant/associate director(s), psychometrician(s) and research specialist(s), as well as statistical programming at the TIMSS and PIRLS International Study Center.
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Demonstrated experience with technical data analytics, including relevant programming languages (R, SQL), data visualization (Tableau, D3. Demonstrated experience with statistical analyses related to data collected using social science research methods, including event history analysis, social network analysis, multivariate statistical approaches, scale design, factor analysis and validation.
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Overseeing or acting as intermediate between Data Management, Statistical Programming and external data provider regarding external data specifications, data, and technical issues. Experience in technologies such as Medidata modules (RAVE, Coder, RTSM, eCOA), Veeva eTMF, eClinical Solutions Elluminate, SAS LSAF.
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Ensure the statistical programming system, processes and deliverables are aligned with relevant regulatory requirements such as clinical study reporting (e.g., ICH E3), electronic records handling (e.g., Chapter 21 of the US Code of Federal Regulation – Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards.
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Outstanding candidates will possess the above plus quantitative coursework (e.g. math, statistics, informatics, computer programming), proficiency in statistical programming skills (such as STATA, SAS, or R) and experience in using GIS software such as ArcGIS/ArcGISPro.
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We are seeking an individual to develop and implement specialized statistical techniques and statistical programming using SAS to analyze and manage administrative data for individuals enrolled in Medicare and Medicaid.
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Demonstrated problem-solving, analytical, and multitasking skills with a good understanding of clinical research, statistical programming and CDISC standards. A technical and innovative role that partners with statistical programming, clinical analytics, data standards, statistical sciences, data sciences and information technology experts to implement next generation clinical data analysis ecosystem.
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Ph. D. degree in Biostatistics, Epidemiology, Computational Biology, Bioinformatics, Genetics/Genomics or related field or M.D. degree Programming skills (SAS and/or R) preferred This position is a postdoctoral training opportunity which provides a bi-monthly stipend.
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Are you passionate about leading and supporting statistical programming activities to support drug development? As our new Senior Manager or Associate Director, Statistical Programming (level commiserate with experience), you will manage internal and external resources to lead, or support assigned project statistical programming activities.
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Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM). Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
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Prior experience must include: Development of stirred-tank, wave, and static bioreactor processes for cell and gene therapy applications scalable to at least 25 L (3 yrs); adaptation of mammalian cells to culturing in BioFlo, XDR, Xuri, and G-Rex platforms (3 yrs); planning DOE-based studies and performing multivariate statistical analysis on large data sets in JMP and Minitab (2 yrs); Programming liquid handling robots and high-throughput systems (2 yrs.
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statistical programming jobs in Cambridge, MA
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