
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
🌐 India, United Kingdom, +1 more countries – Remote
⏰ Full Time
🟠 Senior
🖥 Software Engineer
👻 Ghost score 25%
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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.
• Prepare R and SAS programming scripts to generate NONMEM analysis input datasets for PK and/or PD analysis • Modify variable definition files for NONMEM input datasets • QC NONMEM input datasets generated by other PM support staff and document QC activities, findings and follow-up actions • Generate NONMEM e-submission packages, including input datasets, control files, output parameter files, output table files and supporting documents • Ensure e-submission packages meet naming conventions, formatting, folder structure and assembly server requirements • Guide new or junior CPP community members through the DataFlow process • Guide new or junior CPP community members through the Data Collection Tools review process • Collaborate with Data Management, Programming, BAN/BDS, EPOD and external vendors on data collection, formatting and representation • Revise, update and create SOPs, job aids, templates and training materials • Improve CPP processes for dataset creation, dataset QC and e-submission package preparation • Support Secure exchange medium setup
• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field • At least 6 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent • At least 4 years of related experience with a master’s degree or above • Strong SAS data manipulation, analysis and reporting skills • Solid experience implementing 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 clinical trial data manipulation, analysis and reporting • Submissions experience utilizing define.xml and other submission documents • Excellent analytical and 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 • Autonomy and ownership • Collaboration with global and cross-cultural teams
Apply Now🔥 12 hours ago
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