Drug Safety expert proficient with the latest and upcoming trends in drug safety required for long term advanced safety analytics advisory. An RNA based platform with multiple indications, applying advanced safety analytics to support the entire portfolio, as opposed to only one indication at a time, is a core strategy for the drug sponsor. Expert […]
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Drug Safety Scientist required at 30% of FDA. Must be expert in drug safety statistics. For the particular asset under development the safety profile is extremely strategic. The main competitor product’s safety profile is not ideal but since there are no other treatments it is the primary product for this condition. This asset has similar […]
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A software vendor specializing in pharmaceutical R&D statistical software seeks stats SME (subject matter expert) review and feedback of new release. Tasks include- getting a demo, temporary login, working with product manager, independently reviewing and testing features, and providing feedback including UI/UX (user interface/user experience), overall utility, competitive fitness, other. Deliverables: written report and presentation […]
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Small niche CRO requires RWD/RWE Stats Programmer Expert for ongoing project, anticipated time- 25%. Must have RWE/RWD stats programming experience- experience with datasets from EMR as well as EDC, ICD9 codes, etc.
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A niche CRO requires a strategic RWE expert for a long term project. Anticipated time is 25% FTE. Must be well rounded- have knowledge of regulatory submissions including RWD data, have been exposed to use of RWD as part of a trial such as a control arm, epidemiology methods for observational studies, and other aspects […]
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Small, MA based Phase 3 sponsor in need of a Data Management Lead. Will report to Head of Biometrics, experienced in all aspects of Data Management. This role is heavy on vendor management and data management oversight of CROs and external data managers, as well as data management database systems and technologies.
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This role will provide leadership in all aspects of clinical trial research and product development as well as regulatory interactions. Participation in the selection and oversight of the CRO to perform data management, programming, and biostatistics will be included in this role. Consultant will be available to participate in all meetings as needed, whether they […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities Primary responsibility includes oversight of clinical study execution, including project planning, resource management, CRA and CRO management, and ensuring all operational aspects of clinical trials […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities Primary responsibility of this position includes, but is not limited to the following: • Managing the Statistics, Statistical Programming and Data Management functions • Supervising […]
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Needed asap: seasoned programmer that has extensive experience with BIMO FDA guidance, programing ,and the creation of define.pdf etc.
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Emerging patient data technology start up in need of an independent expert on patient data privacy. Company intends to ingest de-identified data from partner healthcare providers in the US, Germany, UK, France, Spain and Italy on an ongoing basis. End goal is to simulate, as close as possible to true patient data without violating privacy […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]
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Services Summary: The Clinical Data and Systems Manager Lead will execute and provide input on all aspects of clinical data and systems management, including CRO interface and oversight. The focus of this role will be to provide Clinical Data Management and Clinical Data Systems Management that includes management oversight of CDM deliverables from CROs and […]
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