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Reporting to the VP of Biometrics, you will support both early and late phase oncology products, interact with regulatory officials on all statistical related matters, oversee development plans, and provide strategies for clinical study design, endpoint selection, sample size calculations, statistical analysis plans (SAP) and more.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Provides advanced technical statistical programming leadership to the Statistical Programming function within Biometrics and be a technical resource for statistical programmers.
$125,700 - $182,250 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality. The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with some guidance and mentoring on new and complex issues.
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Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Sr. Statistical Programmer provides expertise in SAS programming and related processes to the Biometrics group, including implementation of CDISC standards, as well as ICH and FDA guidance on data and reporting standards.
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Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
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Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting.
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Experience utilizing statistical software for design and analysis of clinical trials (e.g., SAS, R, EAST, FACTS)Proficient R programming skills are required. In addition, the Associate Director of Biostatistics will collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation.
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A minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development, supporting regulatory filings (e.g. NDA, BLA, MAA). Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Vice President, Head of Biometrics will report to the Chief Medical Officer and be responsible for creating and implementing both the near-term and long-term strategic direction for Biostatistics, Statistical Programming, and Clinical Data Management across all therapeutic areas and phases of development while ensuring systems, capabilities, and resources are in place to optimize the design/ conduct and analysis/interpretation of clinical trials and clinical data, respectively.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Summary of Position Head of Biometrics and Data Integrity, as the experienced biostatistician will oversee and guide the statistical work across Curium early and late phase clinical development, HEOR/RWE and medical affairs studies which includes biostatistics and clinical programming work performed by external vendors.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
Full-timeRemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Reviewing key planning documents such as statistical analysis plans, data presentation plans, and data review plans to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements, and assessing the impact on programming activities.
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Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration. Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
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The incumbent will partner with DTE and business leadership to develop capabilities and system roadmaps that align to support business strategy and drive delivery of the technology portfolio across Biometrics and Clinical Data and Standards Platforms, including but not limited to: Metadata Repository (MDR), Clinical Data Workbench, Statistical Computing Environment and other Biometrics platforms.
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