Clinical Outcomes Solutions
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
Senior Biostatistician, FSP
Job not on LinkedIn
November 22
Clinical Outcomes Solutions
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
đź“‹ Description
• Providing statistical support to clinical studies • Participating in the development of study protocols, including participation in study design discussions and sample size calculations • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Performing statistical analyses and interpreting statistical results • Preparing clinical study reports, including integrated summaries for submissions • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
🎯 Requirements
• Master’s degree in statistics or a related discipline. Ph.D. strongly desired. • 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. • Experience working for a CRO is strongly desired. • Experience with oncology is a bonus. • 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 & implementation of CDISC requirements for regulatory submissions. • Adept in ADaM specifications generation and QC of datasets. • The ability to build strong external & internal relationships and motivate a regional or global team. • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
🏖️ Benefits
• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
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