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Knowledge of ICH-GCP, CDISC/ CDASH standards and relevant regulatory guidelines. Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave). Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices. Knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping.
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At least 2 years demonstrated applied knowledge with one or more of the following: SDTM / CDASH / CDISC. Working knowledge of one or more of the following languages: SAS, R, SQL, Python. This role will support the group's core responsibility to ensure data received by BioMarin, from an outside source, is fit-for-purpose for all downstream activities by conforming with defined standards, specifications, and exchange requirements.
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Partner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness. Familiarity with CDISC SDTM and ADaM specifications and associated regulatory guidance.
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Review CRO deliverables and perform acceptance checks and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards. Familiar with relevant industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes' biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
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Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM). Create CDISC SDTM and ADaM files, SAS export files, Define. Solid knowledge of other software such as SpotFire, R Shiny etc.
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Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions. At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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XML documents and reviewer’s guides per CDISC and FDA specifications and guidelines using standard tools and templates. Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
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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 11and ICH guidelines.
$173,700 - $208,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrate knowledge in research design, system validation, E2B / CDISC, standard coding dictionaries (MedDRA) Experience in developing drug safety data management standards (CDISC, SDTM, ADAM.
$93,000 - $149,000 a yearFull-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
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Programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer's Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response.
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Location: home-based in the U.S. or CanadaSummary: IQVIVA is hiring a CDISC Standards Expert to be dedicated to a prominent pharmaceutical company, supporting our client's long-term data standards initiatives.
$119,400 - $203,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The candidate will support the Head of Statistical Programming to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives.
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Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations.
Full-timeExpandApply NowActive JobUpdated 2 days ago
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