Senior Biostatistician, FSP

Job not on LinkedIn

🔥 5 minutes ago

🌐 United Kingdom, Spain, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇸🇪 Sweden – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 25%

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Provide statistical support to clinical studies. • Participate in study protocol development, study design discussions, and sample size calculations. • Review CRFs and data review guidelines; develop statistical analysis plans, including analysis dataset and TLG specifications. • Perform statistical analyses and interpret statistical results. • Prepare clinical study reports, including integrated summaries for submissions. • Present and explain methodology and consequences of decisions. • Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines. • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros. • Participate in development of CRFs, edit check specifications, and data validation plans. • Review and/or author data transfer specifications for external vendor data. • Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals. • Review and/or author SOPs and work instructions related to statistical programming practices. • Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions. • Support medium-complexity clinical trials from design through archival and contribute to project-level activities.

🎯 Requirements

• Minimum of Bachelor's degree in statistics or a related discipline. • 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. • Experience working for a CRO is strongly desired. • Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions. • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus. • Solid understanding and implementation of CDISC requirements for regulatory submissions. • Adept in ADaM specifications generation and QC of datasets. • Ability to build strong external and internal relationships and motivate a regional or global team. • Effective communicator able to explain methodology and consequences of decisions in lay terms.

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities

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