Amber Randall Email and Phone Number
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Amber Randall is a Director, Data Analytics - Fred Hutchinson Cancer Center - SCHARP at Fred Hutch. She possess expertise in clinical trials, biostatistics, molecular biology, gcp, clinical data management and 17 more skills. She is proficient in Dutch.
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Director, Data Analytics - ScharpFred Hutch Nov 2018 - PresentSeattle, Wa, UsProvides leadership, direction, oversight and strategic planning for a team of nearly 40 Statistical Research Associates and Managers in support of nearly 100 active clinical studies with a focus in HIV and other infectious disease prevention and treatment in collaboration with multiple research networks and academic, non-profit, and industry partners. -
Director, Statistical ProgrammingAxio Research Mar 2015 - Nov 2018Seattle, Wa, UsProvide leadership, direction, and oversight for statistical programming activities and staff. Direct more than a dozen Statistical Programmers in collaborative teams within the Biostatistics Department in the support of over 100+ active contracts. Collaborate with CEO and senior Biostatistics management to streamline departmental goals and operations and develop and implement strategic business plans. Direct statistical programming infrastructure planning, implementation, validation, and maintenance. Write and revise Statistical Programming Standard Operating Procedures (SOPs) and ensure regulatory compliance and adherence to good clinical practices (GCPs). Develop systems to improve work flow, training, and long term project tracking efficiency. Maintain knowledge of industry standards, practices and developments. Conduct annual reviews, recruit and train new programming staff. Represent Axio at professional meetings and conferences. -
Project DirectorAxio Research Mar 2012 - Nov 2018Seattle, Wa, UsManage projects related to the statistical reporting of clinical data for industry and grant-funded trials, including the facilitation of data monitoring committees/data safety monitoring boards (DMCs/DSMBs), oversight of the production of clinical statistical reports (CSRs), pre-clinical reports, statistical analysis plans (SAPs), data quality reports, and other general statistical services in fields of oncology, toxicology, cardiology, and vaccine development. Oversee the completion of other programming projects including the implementation of CDISC standards and production of SDTM and ADaM-compliant datasets. Coordinate resources to assure deliverables meet specifications, timelines and budget. Manage client expectations and communications. Ensure accurate billing and internal project tracking and reporting. -
Manager, Statistical ProgrammingAxio Research Feb 2013 - Feb 2015Seattle, Wa, UsOversaw general operations of Statistical Programming resources and interactions within the Department of Biostatistics and entire company. Directed and managed a team of more than a dozen Statistical Programmers, conducted annual reviews, recruited and trained new programming staff, efficiently allocated programming resources over 100+ projects within a department of 30 biostatistics staff. Collaborated with human resources to complete work documentation for international employees. Worked closely with biostatistics management to streamline departmental goals and operations. Collaborated with CEO and senior management in developing and implementing strategic business plans. Participated in statistical programming infrastructure planning, implementation, validation, and maintenance. Assisted in drafting of bids and proposals and grant writing. Wrote and revised SAS Programming Standard Operating Procedures (SOPs) and assured regulatory compliance and adherence to good clinical practices (GCPs). Developed systems to improve work flow, training, and long term project tracking efficiency. Maintained knowledge of industry standards, practices and developments. -
Sas Programmer SupervisorAxio Research Jul 2011 - Feb 2013Seattle, Wa, UsManaged a team of 6-7 SAS Programmers. Allocated programming and statistical resources for 100+ projects within a department of 25 biostatistics staff. Collaborated with senior Biostatistics management in developing a strategic plan for the Biostatistics Department. Recruited and trained new programming staff. Facilitated new annual review process. Provided input into statistical programming infrastructure decisions. Ensured compliance with internal Standard Operating Procedures and GCP guidelines. Contributed to maintenance and revision of Standard Operating Procedures. -
Project ManagerAxio Research Sep 2009 - Mar 2012Seattle, Wa, UsCollaborated with Project Directors and statistical and programming staff to manage the production of deliverables including Data Monitoring Committee/Data Safety Monitoring Board reports, FSRs, pre-clinical statistical reports, DTAs, data quality reports, and other general tasks. Coordinated day-to-day operations and staff resources to track and maintain timelines. Facilitated client communications and meetings. Created specification documents and developed tools to track programming and validation activities as well as assure proper documentation. Provided additional SAS programming support. Contributed to business development activities including drafting of bids, proposals, and grants as well as Standard Operating Procedure development and maintenance. Managed budgeting and billing and allocations requests for projects. -
ProgrammerAxio Research Sep 2008 - Aug 2009Seattle, Wa, UsProgrammed Oracle derivations in PL/SQL in support of data cleaning activities. Programmed SQL queries in support of data discrepancy reports. Defined and drafted work instructions for improved data cleaning processes. Designed, tested, and aided in administration of test and production databases in ClinTrial. Reviewed and resolved data cleaning issues to preserve quality control of data. Collaborated successfully with Project Director and project team, including Data Technicians, Programmers, and Database Administrator to address database input/output design. Collaborated with statisticians to interpret protocols and SAPs and to specify dataset and report programming for statistical analyses. Wrote and edited SAS code to program and validate analysis datasets, tables, listings, and figures. Applied proprietary software to produce statistical tables. Assembled final statistical reports. -
Data CoordinatorAxio Research Jan 2008 - Aug 2008Seattle, Wa, UsSpecified, programmed, and tested clinical study databases and data cleaning systems. Collaborated with Project Directors and project team, including Data Technicians, Programmers, and Database Administrator to address database input/output design. Communicated with sponsor study teams to review and resolve data queries to preserve quality of data. Proposed and implemented methods to improve process flow and efficiency. Programmed and edited SAS code to test analysis datasets and TLFs. -
Research Technician/Graduate Student ResearcherSeattle Biomedical Research Institute Jun 2005 - Dec 2007Seattle, Wa, UsLaboratory of Dr. Patrick DuffyStudied functional and protective antibodies specific to Plasmodium falciparum var2csa isolated from sera collected from Tanzanian women of varying gravidity and malaria protection levels. Applied research methods to define functional protection from pregnancy malaria in these subjects. Standardized and optimized assays to measure the ability of maternal sera to inhibit binding of P. falciparum to placental tissue and immobilized molecules. Coordinated development of software and methodology for automated counting of binding inhibition assays. -
Graduate Student ResearcherUniversity Of Washington Sep 2004 - Jun 2005Seattle, Wa, UsLaboratory of Dr. Patrick DuffyApplied in-situ hybridization technology to identify tissue-specific locations of upregulated genes that may influence pregnancy malaria.Laboratory of Dr. Kenneth StuartApplied tandem mass spectroscopy techniques to identify novel mitochondrial proteins in Trypanosoma brucei.Laboratory of Dr. Leonidas StamatatosStudied the role of glycosylation sites on the HIV-1 envelope protein in T cell entry. -
Medical Research Technician/Graduate StudentTulane University Jun 2003 - Sep 2004New Orleans, La, UsLaboratory of Dr. Frank CogswellStudied cytokine response to Plasmodium infection in a macaque model using microarray technology and molecular biology techniques. -
Research TechnicianSeattle Biomedical Research Institute Jul 1999 - Dec 2002Seattle, Wa, UsLaboratory of Dr. Marilyn ParsonsStudied nucleolar signaling pathways and interactions of nucleolar proteins in Trypanosoma brucei.
Amber Randall Skills
Amber Randall Education Details
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University Of WashingtonPathobiology -
Tulane UniversityTropical Medicine And Parasitology -
Seattle Pacific UniversityBiochemistry
Frequently Asked Questions about Amber Randall
What company does Amber Randall work for?
Amber Randall works for Fred Hutch
What is Amber Randall's role at the current company?
Amber Randall's current role is Director, Data Analytics - Fred Hutchinson Cancer Center - SCHARP.
What is Amber Randall's email address?
Amber Randall's email address is am****@****rch.com
What is Amber Randall's direct phone number?
Amber Randall's direct phone number is +120654*****
What schools did Amber Randall attend?
Amber Randall attended University Of Washington, Tulane University, Seattle Pacific University.
What skills is Amber Randall known for?
Amber Randall has skills like Clinical Trials, Biostatistics, Molecular Biology, Gcp, Clinical Data Management, Sas Programming, Sas, Project Management, Cro, Biotechnology, Parasitology, Pharmaceutical Industry.
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