Clinical Outcomes Solutions
Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.
Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics
Senior Statistical Programmer
March 10
Clinical Outcomes Solutions
Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.
Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics
📋 Description
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) • Production and QC / validation programming • Generating complex ad-hoc reports utilizing raw data • Applying strong understanding/experience of Efficacy analysis • Creating and reviewing submission documents and eCRTs • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries • Performing lead duties when called upon • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. • Being adaptable and flexible when priorities change
🎯 Requirements
• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. • Study lead experience, preferably juggling multiple projects simultaneously preferred. • Strong SAS data manipulation, analysis and reporting skills. • Solid experience implementing the latest CDISC SDTM / ADaM standards. • Strong QC / validation skills. • Good ad-hoc reporting skills. • Proficiency in Efficacy analysis. • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. • Submissions experience utilizing define.xml and other submission documents. • Experience supporting immunology, respiratory or oncology studies would be a plus. • Excellent analytical & troubleshooting skills. • Ability to provide quality output and deliverables, in adherence with challenging timelines. • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
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