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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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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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BASIC QUALIFICATIONS Minimum bachelor's degree in computer science, computer engineering, bioinformatics, or related engineering/scientific fieldMinimum 7 years of experience in similar roles in technology-based organizations or as a Business Lead for technology programsPrior experience with clinical operational data management and reporting is highly preferred.
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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The Senior Manager/Associate Director, Biostatistics will lead statistical analyses for early development of clinical trials, support investigators and researchers on experimental design, and collaborate closely with internal teams while reporting to the Head of Biometrics.
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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. Oversees and validates vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions.
$125,700 - $182,250 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Reporting to the Vice President/Head of biometrics, the Head of Statistical programming will be responsible for leading all statistical analysis and programming for our innovative clinical programs.
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
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Experience working with noisy intelligence and operational data sets from multiple disparate sources to include unstructured, structured and sensor data in many disciplines such as all-source reporting, geographic information systems, biometrics reporting, imagery intelligence, signals intelligence, human intelligence, and open-source intelligence.
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Provide scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff. Reporting to the CMO, the Medical Director/Senior Medical Director, Clinical Development will play a key role at all stages of clinical development programs from the drug discovery stage through product registrations world-wide.
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This role provides statistical input into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies.
$175,000 - $241,667 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Develop IVR / Speech applications using CVP Studio, VXML, and Java - Integrate to backend systems such as web services, databases, legacy 3270, fax, CTI, and reporting. Nuance MRCP (SWMS or Nuance Speech Server) and Licensing components - Voice Biometrics and Nuance SpeechSecure and Verifier 4.0.
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This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing.
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Partnering with the CMO, you will be key in leading the clinical development team in developing, sharing and embedding best practice ways of working across all the GPTs and clinical teams covering program design, delivery, reporting and in support of regulatory interactions and commercialization of Rocket’s exciting gene therapy portfolio to deliver highly differentiated transformative medicines.
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Reporting to the Head of Biometrics, the Director of Biostatistics will support oncology drug development, providing statistical leadership and oversight to the development plans, regulatory interactions, and commercial evaluation of investigational compounds in one or more indications.
$190,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago
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