Clinical Research

• 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.

Explore Senior Biostatistician, FSP at Clinical Outcomes Solutions. Review requirements and application details.

Clinical Research jobs in Sweden

Senior Biostatistician, FSP

Clinical Feasibility Leader