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Katalyst Healthcares & Life Sciences

Clinical SAS Programmer

Newark, NJ, US · On-site · Contract

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About the role

StatisticsClinical ResearchCommunication
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. - We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.  Responsibilities: - Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). - Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. - Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. - Provides input in the design and development of case report forms and clinical databases. - Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs. - Programs for quality checks for clinical study raw data and report the findings to Data Management. - Provides input in the design and development of case report forms and clinical study databases. - Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming.Requirements: - MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years. - Experience in providing statistical programming support to early and late phase clinical trials. - Excellent skills in SAS programming and statistical reporting. - Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements. - Familiarity with FDA and ICH regulations and guidelines. - Excellent problem-solving skills. - Good written and verbal communication skills and organizational and documentation skills. - Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc. - Ability to prioritize and multi-task effectively. - Demonstrated positive attitude and the ability to work well with others. All your information will be kept confidential according to EEO guidelines.