
51 - 200 employees
💼 Consulting
🏥 Healthcare
🧬 Biotechnology
Consulting • Healthcare • Biotechnology
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.
🔥 0 minutes ago
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51 - 200 employees
💼 Consulting
🏥 Healthcare
🧬 Biotechnology
Consulting • Healthcare • Biotechnology
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.
• Work fully embedded within one pharmaceutical client while supported by Cytel • Support or lead one or more Phase I-IV clinical trials • Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy (ISS/ISE), using SAS programming • Generate and validate SDTM and ADaM datasets/analysis files, tables, listings, and figures (TLFs) • Perform production and QC / validation programming • Generate complex ad-hoc reports using raw data • Apply expertise in efficacy analysis • Create and review submission documents and eCRTs • Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries • Perform lead duties when called upon • Adapt to changing priorities and meet deadlines
• Bachelor’s degree in Statistics, Computer Science, Mathematics, etc. • At least 5 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or master’s degree or equivalent • Study lead experience 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 the drug development life cycle and manipulation, analysis and reporting of clinical trial 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 within challenging timelines • Ability to work effectively in a globally dispersed team environment with cross-cultural partners
• Consistent training, development and support • Significant professional growth opportunities • Fully remote work arrangement • Autonomy and ownership in a sponsor-dedicated role
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