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Lead statistical programming activities for regulatory submissions following CDISC standards. Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
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Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards. In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11 and ICH guidelines.
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Demonstrated understanding of CDISC and SDTM requirements and implementation guidelines, able to create and validate CDISC standard datasets. 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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Knowledge of CDISC and SDTM standard terminology. The Sr. Clinical Data Manager will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.
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Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation.
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Familiarity with CDISC standards, IWRS, ADaM Specs, and review define documents. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs.
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Manages creating CDISC SDTM and ADaM files, SAS transport files and Define. This is an onsite hybrid position reporting to the Vice President, Head of Biostatistics and Statistical Programming.
$255,000 - $280,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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They will lead cross-functional team members to perform proper Data Reviews, and provides guidance on CDISC standards. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
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Experience working with an Electronic Data Capture system (EDC) (e.g. Medidata Rave) and with other databases (e.g. Central Imaging, IVRS/IWRS) Oversees the creation and approval of Data Management study documentation by CROs and other vendors, to include CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Experience must include in-depth knowledge of CDISC in SDTM and ADaM, Metadata, and controlled terminologies. Tanner and Associates is recruiting a Senior Manager, Statistical Programming/SAS Programmingfor a large biotech company based in San Francisco.
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The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
$173,700 - $208,500 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies and Pinnacle 21 validator. This is a ground floor opportunity to help to build the statistical programming function within the Biometrics department.
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Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors.
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Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation. Review and file study documentation in the Trial Master File (TMF.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Follow CDISC, SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and key TFLs generated by the CRO. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease and lupus nephritis.
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cdisc job in South San Francisco, CA
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