Statistician Katalyst HLS

Responsibilities: Prepare statistical analysis plans; develop table shells and ADaM specs for phase 2/3 clinical trials Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc / data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Provide statistical support for integrated reports, submissions preparation, and post-submission activities. Provide statistical analysis methods and SAS procedures to programmers
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Clinical Narrative Writer Katalyst HLS

Skills/Knowledge Required: Extensive experience writing all types of clinical and regulatory documents for worldwide use, expertise in the Oncology therapeutic areas, experience in worldwide registration studies and large studies, understanding and good use of all study documents. Protocol, SAP, CRF, SMQs, expertise in MS WORD, including the ability to solve technical problems with WORD templates, excellent grammatical and communication skills. Both written and oral, knowledge of FDA and ICH guidelines, ability to work with multiple complex projects at a time, ability to anticipate and resolve problems working independently, Experience working with automated data solutions in clinical documents, experience working with CROs, proficiency in data interpretation, sound organizational skills. Experience interfacing with multiple teams, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings.
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Clinical Project Lead Katalyst HLS

Roles & Responsibilities Designs clinical studies, formulates and conducts scientific investigations, and due diligence studies related to Client products. Interprets and presents results. Prepares technical reports, abstracts. Identifies appropriate clinical and/or other defined testing to address clinical risks for product changes. Develops safety and efficacy requirements and a clinical test plan to address S&E, Regulatory and Marketing requirements products and gains functional approval of such. With the support of the MA team, ensures safety, efficacy and clinical utility of the product, technology and related labelling/promotional material.
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Clinical Data Analyst Katalyst HLS

Roles & Responsibilities: At Excite, we want you to succeed. We want to help you reach your goals and find a satisfying and challenging work environment. For the Clinical Data Analyst position, you should meet the following criteria: Knowledge of standard business intelligence tools and ability to construct and interpret SQL statements Experience with statistical analysis, including application of statistical methods Experience with enterprise data warehouse structure and source systems Soarian experience (Clinicals, Financials, and Web Publishing)
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Clinical SAS/SDTM Programmers Katalyst HLS

Job Responsibilities: Develop and validate SAS ® programs to produce high-quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, tables, listings and figures. Review and provide feedback on deliverables from other clinical groups, including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms. Clear and proactive communication with Study and Project teams to clarify requirements and specifications, update on assignment status and convey data irregularities. Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency. Ensure the edit check specification and data quality for ongoing clinical study. Keep abreast of SAS enhancements and supports achievement of major reporting delivera
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Clinical Research Associate III (CRA III) job - Katalyst HealthCares & Life Sciences - Raritan, NJ

May 9, 2018 - Clinical Research Associate III (CRA III) - p b Job summary: /b /p ul li The In-House Clinical Research Associate will work closely with the Lead CRA and Investigational Sites by providing
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Senior Statistical Programmer job - Katalyst HealthCares & Life Sciences - Pleasanton, TX | Indeed.com

May 9, 2018 - Senior Statistical Programmer - p Job SummarySr. Statistical Programmer will be responsible for supporting statistical programming activities for registrational and
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Clinical Data Manager job - Katalyst HealthCares & Life Sciences - Houston, TX

May 4, 2018 - Clinical Data Manager - p b Responsibilities: /b /p ul li Manage clinical trial databases: Review synopsis and attend Synopsis Review Committee (SRC) meeting Review
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Clinical Data Manager Katalyst HLS

Responsibilities: Manage clinical trial databases: Review synopsis and attend Synopsis Review Committee (SRC) meeting Review protocols for proper data capture including Case Report Form (CRF) design and CRF completion guidelines Design eCRF specifications according to the protocol Develop eCRF guidelines according to design of the eCRF Lead eCRF development until finalization along with Study Team members Assigned to more complex studies Lead in the development of a Data Management Plan (DMP), when applicable, that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate data cleaning in accordance to our Comprehensive Data Review Plan (CDRP) Develop and test edit specifications Develop scripts for UAT as well as perform/coordinate UAT testing
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Process Development Technician Katalyst HLS

Responsibilities Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility Operates buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved. Interacts across the asset to achieve production schedule. Archives documentation according to established procedures. Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
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Regulatory Publisher, Intern Katalyst HLS

Responsibilities: Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.) Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications.
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