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Form of workData Specialist, Safety Pharmacology, Preclinical LaboratoryAltasciences has an opening for a scientific data specialist whose primary responsibility will be the extraction and analysis of non-clinical telemetry data within the Safety Pharmacology Team. Experience with Ponemah data analysis software is preferred. The Data Specialist will work closely with the study team to help assure high quality data recordings and accurate data analysis and reporting.There is potential for the position to be partially or entirely remote.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements.
Altasciences helps sponsors get better drugs to the people who need them, faster.The Safety Assessment Data Specialist works collaboratively with designated Study Director(s), Contributing Scientists and Principal Investigators, as appropriate, to provide professional support for data management, analysis, and interpretation, assisting with the reporting process, in compliance with GLP standards. The Safety Assessment Data Specialist assists with administration functions to maximize the business value of internal systems and/or processes (e.g. Ponemah), including, but not limited to, method validation, software validation, personnel training, study set-up and scheduling, and technological support.Main Responsibilities:Use of Ponemah data analysis software to extract and summarize telemetry data recorded during safety pharmacology studies.
Signals for routine analysis include blood pressures, ventricular pressures and derivatives, ECG intervals, respiratory parameters. Familiarity with the signals being analyzed and data derived is necessary. Capability for performing arrhythmia analysis is desirable.Tabulation and transformation of complex data sets.Generation of graphs for reporting purposes.Collaboration with statistician to provide statistical analysis of data.Scientist will work with the study director and reporting team to meet study timelines.Maintenance of historical databases.Provide training of staff on routine electronic data capture system (EDCS) setup, recording, and analysis procedures.Assist in resolution of EDCS system issues (e.g., system function disruptions, data quality problems, etc.).Write/revise/review SOPs as appropriate and assist in preparation of study related documents.Assist in the development of new capabilities needed to grow the business unit.Contribute efforts towards software/system acquisition, implementation and validation as appropriate.May act as project lead for the development of new capabilities in line with the business model (internal studies only).Desired Candidate:B.S./M.S.degree, preferably in scientific or technical discipline or equivalent combination of education, related experience and/or certified training.
Experience with cardiovascular physiology and arrhythmia interpretation preferred.Ability to utilize and interpret appropriate mathematical and statistical methods for analysis of scientific study data.Minimum 1 year in a scientific capacity in biomedical research in an academic, industrial, or Contract Research Organization (CRO) environment.Verbal and written communication skills in English; the ability to read, analyze, understand, discuss, and interpret complex scientific and regulatory documents.Proficient in the use of MS Office (Word, Excel, PowerPoint) and Ponemah software desired.Ability to multi-task and maintain organization and meet timelines in a fast paced, changing environment. Strong planning and organizational skills.Ability to work effectively and cooperatively in a team environment under significant time pressure.Demonstrated attention to detail and consistent ability to operate with accuracy and quality. Ability to successfully operate independently with minimal guidelines.Good understanding of GLP regulations.Employment Type: FULL_TIME
