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The Director of the Office of Data Quality will also interact closely with other DF/HCC and DFCI offices that support clinical research including: Clinical Trials Research Informatics Office, Office of Human Research Subjects, Clinical Trials Offices from all DF/HCC consortium sites, and DF/HCC Administration.
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Reporting directly to the Head of Translational Medicine, this individual will oversee the design of translational/biomarker strategies and collaborate closely with cross-functional teams, including Research, Clinical Development, and Regulatory Affairs, as well as external CROs to ensure their seamless implementation into our clinical trials.
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Coordinate with data management study leads, clinical operations, internal stakeholders and external vendors to map non-EDC data from collection through analysis. The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne's clinical studies.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
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Guide and advise clinical development study teams on the design and collection of natural history data to better understand disease progression including risk factors and optimal endpoints for use in clinical trials.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Master’s degree in data science/bioinformatics/computational biology/machine learning or related field. Support various teams for the processing and interpretation of next-generation sequencing (NGS) data and ensure timely delivery of results.
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Master Data Management: Informatica MDM. Top must-have skills: Minimum 8 years of related experience Data Mesh, domain-driven design Data, Object modeling Database/Data warehouse - AWS RDS, Snowflake, AWS Redshift.
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Thymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.
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Engage with other Global DD&T (GDD&T) platform leads to ensure infrastructure is built to support all internal & external digital experiences; collaborate with Chief Data Officer (CDO), Chief Technology Officer (CTO), and Chief Information Security Officer (CISO) to ensure strict compliance with data, technology, and information security standards.
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Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization.
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Lead the adoption of DataOps practices, fostering collaboration between data engineering, data science, and operations teams to streamline the entire data lifecycle. You are fluent with platforms like AWS, Snowflake, Dagster, and dbt at your fingertips, and deploying via tools such as Kubernetes, Docker, and Terraform being second nature, you are primed to spearhead our pursuit of data excellence.
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Lead internal process development, optimization and tech transfer of upstream and downstream process development for clinical development pipeline. Tech transfer of methods and processes to CDMO for early stage clinical manufacturing.
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The Director of QSP & Data Analytics will be responsible to lead strategic development and execution of innovative data and predictive analytics methodologies to support translational, clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration.
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Develop, deploy, and assess the results of at-scale models at varying levels of model granularity encompassing heterogeneous preclinical and clinical data. High proficiency in molecular modeling (chemoinformatics, molecular dynamics and CADD softwares) and machine learning (Deep Learning, Graph Embeddings, Reinforcement and Transfer Learning) and algorithmic analysis of data.
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clinical trials data jobs Title: operations Company: Boston Pharmaceuticals in Needham, MA
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