Statistical Center for HIV/AIDS Research and Prevention (SCHARP) is seeking a CDISC Standards Coordinator to manage CDISC related activities, performing regular review and assessment of CDISC Data Standards, advising of new requirements, tools and reference materials to ensure the consistency of data products to recommended regulatory submission standards. The CDISC Standards Coordinator will support multi-functional teams as a member of the DMU through experience and expertise as the subject matter expert (SME) in data standards. They will possess, demonstrate, and maintain an operational level perspective, focus and communicate effectively as the SME for all CDISC related activities, issues, timelines and deliverables in collaboration with functional leads and leadership.
* Provide subject matter expertise and leadership to SCHARP biometrics staff working with CDISC
* Oversee CDISC product, updates and versioning to ensure ongoing compliance with current standards
* Manage and coordinate CDISC related activities within SCHARP
* Liaise with SCHARP biometrics staff to develop and maintain current defined CDASH, SDTM, and ADaM collection and reporting instruments
* Assist in the definition and development of CDASH/SDTM complaint data collection instruments
* Collaborate in the annotating and mapping of global standard SDTM data content
* Where requested and appropriate, assist with the production of CDISC defined data (e.g. annotations, mapping, datasets, reports)
* Maintain awareness and communicate all pertinent publication updates from CDISC and other agencies that would impact CDISC standard products
* Provide routine updates to SCHARP biometrics in order to ensure current and new staff are aware of materials and training
* Lead CDISC working group(s) as established/requested
* Provide internal training to SCHARP biometrics and our partners as appropriate
* BA / BS degree in Life Sciences, Business Administration/Management
* Completion of formal CDASH, SDTM, ADaM training
* Proficiency in Clinical Data Interchange Standards Consortium (CDISC)
* Applied knowledge of the requirements of submission for Clinical Data Management, Statistics, Statistical Programming
* Experience as a member of a team completing regulatory submissions
* Experience with external data handling of study data preferred
* Excellent verbal and written communication skills, as well as interpersonal skills are required.
* Proficient in Microsoft Office suite of tools
Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.
Careers Start Here.
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at Fred Hutch provides statistical collaboration to infectious disease researchers around the world. SCHARP collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. SCHARP provides statistical and data management services to:
* The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and experts testing preventive vaccines against HIV/AIDS.
* The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV.
* The Microbicides Trials Network (MTN) is collaboration among researchers worldwide who conduct clinical trials using microbial preventions.
* The Collaboration for AIDS Vaccine Discovery (CAVD) is an international network of scientists and experts dedicated to designing a variety of novel HIV vaccine candidates and advancing the most promising candidates to clinical trials.
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