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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.
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The ideal candidate will have extensive knowledge of statistical methodology, proven competencies and interactions with regulatory authorities, a strong understanding of GCPs, and excellent programming skills in both SAS and R. Oncology experience is strongly preferred.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department as applicable.
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RBW has partnered with a patient-focused, mission-driven small biotech in San Francisco in part of their search for a Director of Biostatistics. Our client is looking for a candidate with a PhD in Biostatistics with 9+ additional years of experience, or MS with 13+ years.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Strong programming skills in SAS required, R programming experience preferred. Lead and/or author development of new procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department.
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Represent the biometrics functions on cross-functional and program teams and make strategic contributions to the clinical development plan (CDP) Proficient in statistical programming (SAS or R is required.
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Experience handling data management and statistical programming components, including SAS, CDISC (e.g., SDTM and ADaM), EDC systems, and R (for simulations) or other statistical software. Plan, organize, and execute biometrics activities associated with all regulatory submissions (pre-IND, IND, NDAs/BLAs, post-marketing submission), for example, statistical analysis plans, analysis specifications for clinical trial documents and reports, protocols, investigator brochures, as well as preparation of submission data packages compliant with regulatory standards; Review and analyze safety reporting, perform biomarker analyses and other aspects of clinical trial monitoring.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical coding dictionaries, controlled terminologies, as well as in industry standards for electronic submission of data to FDA.
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Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration. Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM.
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Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
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Proficiency in data analyses using statistical tools such as SAS, Stata, and GraphPad Prism. Director, Biometrics (Clinical Data Coordination & Analysis) Oversee data management and statistical analysis support for the clinical research activities conducted HIV Research Program (MHRP), the Emerging Infectious Diseases Branch (EIDB), and other affiliated programs.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Statistical programming function within the Biometrics department. A comprehensive understanding of SAS/BASE, SAS/STAT/, SAS/GRAPH and SAS macro languages. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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Statistical Programmer, clinical trials, SAS. Provide Statistical Programming support in producing or verifying SAS scripts and outputs for Analysis Files, Tables, Listings, Figures, and any other form of Clinical Trials.
ExpandApply NowActive JobUpdated 7 days ago
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