Study level Biostatistician- part time

Study level Biostatistician- part time

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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Sr. Clinical Project Manager

Sr. Clinical Project Manager

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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Senior Director of Statistics, Statistical Programming and Data Management

Senior Director of Statistics, Statistical Programming and Data Management

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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Seasoned Stats Programmer asap

Seasoned Stats Programmer asap

Needed asap:  seasoned programmer that has extensive experience with BIMO FDA guidance, programing ,and the creation of define.pdf etc. 

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Patient Data Compliance and Governance needed for De-Identified Data project

Patient Data Compliance and Governance needed for De-Identified Data project

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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Manager, Technical Services

Manager, Technical Services

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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Data Management Lead for Phase 2

Data Management Lead for Phase 2

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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